# FDA device clearances in India: 30 since Nov 2024

Updated October 23, 2026.

FDA made 30 device decisions for applicants in India from November 12, 2024 to October 23, 2026: 30 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 25 applicants. The newest, K261670 on October 23, 2026, is Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 )... from Poly Medicure Limited.

## The full list

FDA device clearances for applicants in India: 30 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/country/india

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: 30
- 510(k) and De Novo: 30
- PMA: 0
- Latest decision: October 23, 2026

## Newest decisions

The newest 30 of 30, 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 23, 2026 | K261670 | Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation... | Poly Medicure Limited | India | Substantially Equivalent | 510(k) traditional | LJH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261670) |
| September 27, 2026 | K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | India | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252139) |
| September 14, 2026 | K261517 | qCT Lung (v1.0) | Qure.Ai Technologies Pvt. , Ltd. | India | Substantially Equivalent | 510(k) traditional | QDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261517) |
| June 5, 2026 | K253296 | Digital C-ARM with 3D | Allengers Medical Systems Limited | India | Substantially Equivalent | 510(k) traditional | OXO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253296) |
| May 22, 2026 | K252915 | AiSteth® | Ai Health Highway India Pvt., Ltd. | India | Substantially Equivalent | 510(k) traditional | DQD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252915) |
| May 12, 2026 | K260235 | CellDx-Tissue | Datar Cancer Genetics Private Limited | India | Substantially Equivalent | 510(k) traditional | PZM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260235) |
| April 1, 2026 | K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x... | Poly Medicure Limited | India | Substantially Equivalent | 510(k) special | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252513) |
| January 16, 2026 | K252634 | Imagine® Enterprise Suite | Softlink International Private Limited | India | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252634) |
| January 16, 2026 | K251934 | qXR-Detect | Qure.Ai Technologies | India | Substantially Equivalent | 510(k) traditional | MYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251934) |
| January 6, 2026 | K251165 | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited | India | Substantially Equivalent | 510(k) traditional | SGR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251165) |
| December 16, 2025 | K251893 | SKAN C PULSAR | Skanray Technologies Limited | India | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251893) |
| December 12, 2025 | K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | India | Substantially Equivalent | 510(k) traditional | HKI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252120) |
| November 25, 2025 | K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited | India | Substantially Equivalent | 510(k) traditional | PMC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252289) |
| November 14, 2025 | K251872 | Biomoneta Avata Rx | Biomoneta Research Private Limited | India | Substantially Equivalent | 510(k) traditional | FRF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251872) |
| November 5, 2025 | K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | India | Substantially Equivalent | 510(k) special | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252677) |
| September 23, 2025 | K252644 | PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture... | M/s. Meril Endo Surgery Private Limited. | India | Substantially Equivalent | 510(k) special | NEW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252644) |
| September 8, 2025 | K251610 | qER-CTA (v1.0) | Qure.Ai Technologies | India | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251610) |
| August 28, 2025 | K251594 | truFlex | Syrma Johari Medtech Limited | India | Substantially Equivalent | 510(k) special | NGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251594) |
| August 14, 2025 | K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | India | Substantially Equivalent | 510(k) traditional | HKI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243600) |
| August 11, 2025 | K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | Univlabs Technologies Private Limited | India | Substantially Equivalent | 510(k) traditional | FET | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250462) |
| July 29, 2025 | K243473 | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | Prognosys Medical Systems Private Limited | India | Substantially Equivalent | 510(k) traditional | IZL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243473) |
| May 16, 2025 | K243837 | iBSM | Iorbit Digital Technologies Private Limited | India | Substantially Equivalent | 510(k) traditional | DRG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243837) |
| April 18, 2025 | K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | India | Substantially Equivalent | 510(k) special | MQB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243734) |
| February 27, 2025 | K241595 | EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt , Ltd. | India | Substantially Equivalent | 510(k) traditional | FBK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241595) |
| February 21, 2025 | K242838 | QuickRad | Aikenist Technologies Pvt, Ltd. | India | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242838) |
| December 19, 2024 | K243094 | Quickdent Dental Implant System | Quickdent Devices Private , Ltd. | India | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243094) |
| December 17, 2024 | K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE) | Allengers Global Healthcare Private Limited | India | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242987) |
| November 27, 2024 | K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited | India | Substantially Equivalent | 510(k) traditional | EBF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233273) |
| November 22, 2024 | K242913 | Jasmate® Toothpaste | Jasberry Healthcare Private Limited | India | Substantially Equivalent | 510(k) traditional | LBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242913) |
| November 12, 2024 | K240771 | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | India | Substantially Equivalent | 510(k) traditional | MQB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240771) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Poly Medicure Limited | 3 | October 23, 2026 |
| Allengers Medical Systems Limited | 2 | June 5, 2026 |
| Qure.Ai Technologies | 2 | January 16, 2026 |
| Prognosys Medical Systems Private Limited | 2 | July 29, 2025 |
| Rivarp Medical Pvt., Ltd. | 1 | September 27, 2026 |
| Qure.Ai Technologies Pvt. , Ltd. | 1 | September 14, 2026 |
| Ai Health Highway India Pvt., Ltd. | 1 | May 22, 2026 |
| Datar Cancer Genetics Private Limited | 1 | May 12, 2026 |
| Softlink International Private Limited | 1 | January 16, 2026 |
| Innaccel Technologies Private Limited | 1 | January 6, 2026 |
| Skanray Technologies Limited | 1 | December 16, 2025 |
| Remidio Innovative Solutions Private Limited | 1 | December 12, 2025 |
| Stemtech Medical Devices Private Limited | 1 | November 25, 2025 |
| Biomoneta Research Private Limited | 1 | November 14, 2025 |
| M/s. Meril Endo Surgery Private Limited. | 1 | September 23, 2025 |
| Syrma Johari Medtech Limited | 1 | August 28, 2025 |
| Forus Health Pvt.Ltd | 1 | August 14, 2025 |
| Univlabs Technologies Private Limited | 1 | August 11, 2025 |
| Iorbit Digital Technologies Private Limited | 1 | May 16, 2025 |
| Veol Medical Technologies Pvt , Ltd. | 1 | February 27, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 10 | September 14, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 3 | October 23, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 3 | April 1, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 3 | November 25, 2025 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 3 | December 19, 2024 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 2 | May 22, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 2 | December 12, 2025 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 1 | September 27, 2026 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 1 | May 12, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 1 | January 6, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 1 | August 28, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 25 | October 23, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 5 | April 1, 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/).