# FDA device clearances in Delaware: 36 since Nov 2024

Updated October 21, 2026.

FDA made 36 device decisions for applicants in Delaware from December 13, 2024 to October 21, 2026: 32 510(k) clearances and De Novo grants and 4 PMA approvals and supplements, for 20 applicants. The newest, K261788 on October 21, 2026, is Eden PACS from Higia., Inc. d/b/a Eden.

## The full list

FDA device clearances for applicants in Delaware: 36 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 2 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-clearances/state/delaware

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 36
- 510(k) and De Novo: 32
- PMA: 4
- Latest decision: October 21, 2026

## Newest decisions

The newest 36 of 36, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 21, 2026 | K261788 | Eden PACS | Higia., Inc. d/b/a Eden | Delaware | Substantially Equivalent | 510(k) abbreviated | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261788) |
| October 16, 2026 | K254094 | Endox High Level Disinfectant | Whiteley USA, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | MED | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254094) |
| September 24, 2026 | K254303 | KARL STORZ SUPRALOOP | Karl Storz SE & CO. KG | Delaware | Substantially Equivalent | 510(k) traditional | KNF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254303) |
| September 4, 2026 | K260525 | NextMR Spine | MRI2CT, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260525) |
| September 2, 2026 | K254090 | I-View® | Hologic, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | MUE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254090) |
| August 31, 2026 | K254217 | Aerloom | Evolym, LLC | Delaware | Substantially Equivalent | 510(k) traditional | JOW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254217) |
| August 14, 2026 | K262449 | AdvaView | Advahealth Solutions, LLC | Delaware | Substantially Equivalent | 510(k) special | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262449) |
| July 30, 2026 | K260566 | SMARTVERTIGO™ Vestibular Assessment System | VertigoDx, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | GWN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260566) |
| July 17, 2026 | K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | Delaware | Substantially Equivalent | 510(k) traditional | NFT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261984) |
| June 5, 2026 | K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | Assure Tech., LLC | Delaware | Substantially Equivalent | 510(k) traditional | QYT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260754) |
| May 21, 2026 | K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253245) |
| May 11, 2026 | K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | Delaware | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254228) |
| May 9, 2026 | K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | Delaware | Substantially Equivalent | 510(k) abbreviated | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261145) |
| February 27, 2026 | K251998 | Atellica CH Diazo Total Bilirubin (D\_TBil) | Siemens Healthcare Diagnostics, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | CIG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251998) |
| January 30, 2026 | K251981 | Boston PICO (Boston PICO) | Boston Aesthetics, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251981) |
| January 21, 2026 | K252369 | Boston Pico755 | Boston Aesthetics, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252369) |
| January 12, 2026 | K251988 | Boston iFace (Boston iFace) | Boston Aesthetics, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251988) |
| September 12, 2025 | K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | Tangent Endoscopy, LLC | Delaware | Substantially Equivalent | 510(k) traditional | FBN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251170) |
| August 15, 2025 | K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | Delaware | Substantially Equivalent | 510(k) traditional | NFT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252259) |
| July 31, 2025 | K243341 | Genius AI Detection 2.0 | Hologic, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | QDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243341) |
| May 23, 2025 | K242594 | DEEPECHO | Deepecho | Delaware | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242594) |
| May 22, 2025 | P020027/S042 | Dimension FPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | Delaware | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020027S042) |
| May 22, 2025 | P000021/S047 | Dimension TPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | Delaware | 30-day notice accepted | PMA 30-day notice | LTJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000021S047) |
| April 25, 2025 | K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex... | Siemens Healthcare Diagnostics | Delaware | Substantially Equivalent | 510(k) traditional | JLW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243570) |
| April 16, 2025 | K242647 | MySegmenter (v2.0.0) | Mysegmenter Technologies, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242647) |
| March 13, 2025 | K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System... | Boston Aesthetics, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | FTC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244022) |
| February 24, 2025 | P020027/S041 | Dimension FPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | Delaware | 30-day notice accepted | PMA 30-day notice | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020027S041) |
| February 24, 2025 | P000021/S046 | Dimension TPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | Delaware | 30-day notice accepted | PMA 30-day notice | LTJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000021S046) |
| February 13, 2025 | K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC | Delaware | Substantially Equivalent | 510(k) traditional | LCX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250117) |
| February 13, 2025 | K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF... | Boston Aesthetics, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241832) |
| February 7, 2025 | K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech... | Assure Tech., LLC | Delaware | Substantially Equivalent | 510(k) traditional | NFT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243996) |
| January 16, 2025 | K233770 | Pepper EMS Training System | Pepper Interactive, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | NGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233770) |
| January 15, 2025 | K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy... | Assure Tech., LLC | Delaware | Substantially Equivalent | 510(k) traditional | LCX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243573) |
| December 16, 2024 | K240937 | AIM (N/A) | Inventeur, LLC | Delaware | Substantially Equivalent | 510(k) traditional | CCK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240937) |
| December 13, 2024 | K243281 | LOCK-IN Spinal Fixation System | Lock-In USA Corp | Delaware | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243281) |
| December 13, 2024 | K242668 | Gastro Concepts Air Assist | Gastro Concepts, LLC | Delaware | Substantially Equivalent | 510(k) traditional | FER | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242668) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Assure Tech., LLC | 6 | July 17, 2026 |
| Boston Aesthetics, Inc. | 6 | May 21, 2026 |
| Siemens Healthcare Diagnostics | 5 | May 22, 2025 |
| Karl Storz SE & CO. KG | 2 | September 24, 2026 |
| Hologic, Inc. | 2 | September 2, 2026 |
| Higia., Inc. d/b/a Eden | 1 | October 21, 2026 |
| Whiteley USA, Inc. | 1 | October 16, 2026 |
| MRI2CT, Inc. | 1 | September 4, 2026 |
| Evolym, LLC | 1 | August 31, 2026 |
| Advahealth Solutions, LLC | 1 | August 14, 2026 |
| VertigoDx, Inc. | 1 | July 30, 2026 |
| Avanti Orthopaedics, LLC | 1 | May 9, 2026 |
| Siemens Healthcare Diagnostics, Inc. | 1 | February 27, 2026 |
| Tangent Endoscopy, LLC | 1 | September 12, 2025 |
| Deepecho | 1 | May 23, 2025 |
| Mysegmenter Technologies, Inc. | 1 | April 16, 2025 |
| Pepper Interactive, Inc. | 1 | January 16, 2025 |
| Inventeur, LLC | 1 | December 16, 2024 |
| Lock-In USA Corp | 1 | December 13, 2024 |
| Gastro Concepts, LLC | 1 | December 13, 2024 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 7 | October 21, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 6 | May 21, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 4 | February 27, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 4 | May 22, 2025 |
| [Clinical Toxicology](https://specstream.ai/data/fda-clearances/panel/clinical-toxicology) | 3 | July 17, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 3 | May 11, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 2 | May 9, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 1 | October 16, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 1 | September 24, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 1 | August 31, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 1 | July 30, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 1 | June 5, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 1 | January 16, 2025 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 1 | December 16, 2024 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 29 | October 16, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 4 | May 22, 2025 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 2 | October 21, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 1 | August 14, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).