# FDA device clearances in New Hampshire: 21 since Nov 2024

Updated October 15, 2026.

FDA made 21 device decisions for applicants in New Hampshire from November 27, 2024 to October 15, 2026: 15 510(k) clearances and De Novo grants and 6 PMA approvals and supplements, for 10 applicants. The newest, K262576 on October 15, 2026, is twiist Loop Algorithm from Deka Research and Development Corp..

## The full list

FDA device clearances for applicants in New Hampshire: 21 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 1 row 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/new-hampshire

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: 21
- 510(k) and De Novo: 15
- PMA: 6
- Latest decision: October 15, 2026

## Newest decisions

The newest 21 of 21, 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 15, 2026 | K262576 | twiist Loop Algorithm | Deka Research and Development Corp. | New Hampshire | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262576) |
| October 2, 2026 | K260064 | Neurora | Argus Cognitive, Inc. | New Hampshire | Substantially Equivalent | 510(k) traditional | QPF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260064) |
| September 9, 2026 | K251417 | ReVISION 2 | Argus Cognitive, Inc. | New Hampshire | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251417) |
| July 24, 2026 | K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | New Hampshire | Substantially Equivalent | 510(k) traditional | FRN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253703) |
| June 17, 2026 | K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | New Hampshire | Substantially Equivalent | 510(k) special | QFG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261672) |
| June 3, 2026 | K261530 | iiSure Infusion Set | Deka Research and Development | New Hampshire | Substantially Equivalent | 510(k) special | FPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261530) |
| May 13, 2026 | P120003/S007 | iCast Covered Stent System | Atrium Medical Corp. | New Hampshire | Approved | PMA 135-day supplement | PRL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120003S007) |
| April 13, 2026 | K254078 | HVT 2.0 | Vapotherm, Inc. | New Hampshire | Substantially Equivalent | 510(k) traditional | BTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254078) |
| January 15, 2026 | K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | New Hampshire | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251847) |
| December 22, 2025 | P120003/S009 | iCast Covered Stent System | Atrium Medical Corp. | New Hampshire | Approved | PMA 180-day supplement | PRL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120003S009) |
| October 10, 2025 | K243815 | SoClean 3+ | Soclean, Inc. | New Hampshire | Substantially Equivalent | 510(k) traditional | QXQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243815) |
| September 12, 2025 | P120003/S011 | iCast Covered Stent System | Atrium Medical Corp. | New Hampshire | 30-day notice accepted | PMA 30-day notice | PRL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120003S011) |
| August 20, 2025 | P120003/S010 | iCast Covered Stent System | Atrium Medical Corp. | New Hampshire | 30-day notice accepted | PMA 30-day notice | PRL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120003S010) |
| August 1, 2025 | K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | New Hampshire | Substantially Equivalent | 510(k) traditional | FPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243841) |
| July 7, 2025 | P120003/S006 | iCast Covered Stent System | Atrium Medical Corp. | New Hampshire | Approved | PMA 180-day supplement | PRL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120003S006) |
| May 1, 2025 | P120003/S008 | iCast Covered Stent System | Atrium Medical Corp. | New Hampshire | 30-day notice accepted | PMA 30-day notice | PRL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120003S008) |
| April 2, 2025 | K250930 | twiist system | Deka Research & Development Corp. | New Hampshire | Substantially Equivalent | 510(k) special | QFG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250930) |
| March 11, 2025 | K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | New Hampshire | Substantially Equivalent | 510(k) special | FRN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250357) |
| January 30, 2025 | K243442 | iBOT® PMD | Mobius Mobility | New Hampshire | Substantially Equivalent | 510(k) traditional | IMK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243442) |
| January 16, 2025 | K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | New Hampshire | Substantially Equivalent | 510(k) traditional | FRN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241736) |
| November 27, 2024 | K243354 | Remunity System | Deka Research & Development Corp. | New Hampshire | Substantially Equivalent | 510(k) special | QJY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243354) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Atrium Medical Corp. | 6 | May 13, 2026 |
| Deka Research and Development | 3 | June 17, 2026 |
| Deka Research & Development Corp. | 3 | April 2, 2025 |
| Deka Research and Development Corp. | 2 | October 15, 2026 |
| Argus Cognitive, Inc. | 2 | October 2, 2026 |
| Deka R&D Corp | 1 | July 24, 2026 |
| Vapotherm, Inc. | 1 | April 13, 2026 |
| Sleepnet Corporation | 1 | January 15, 2026 |
| Soclean, Inc. | 1 | October 10, 2025 |
| Mobius Mobility | 1 | January 30, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 7 | July 24, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 6 | May 13, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 3 | October 15, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 2 | April 13, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 1 | October 2, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 1 | September 9, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 1 | January 30, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 10 | October 15, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 5 | June 17, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 3 | September 12, 2025 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 2 | December 22, 2025 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 1 | May 13, 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/).