# Prytime Medical Devices, Inc.

- Location (FDA's records): Boerne, TX
- FDA decisions: 5 (2017–2025): 5 510(k) clearances
- Product codes: MJN (5)
- 510(k) review time since 2016: median 54 days, against 59 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pryor Medical Devices, Inc.: 1 (https://510kreport.com/company/pryor-medical-devices)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Neurescue Aps: 1 (https://510kreport.com/company/neurescue)
- Zien Medical Technologies, Inc.: 1 (https://510kreport.com/company/zien-medical-technologies)
- Front Line Medical Technologies, Inc.: 1 (https://510kreport.com/company/front-line-medical-technologies)

## Its most-cited devices
- K170411: ER-REBOA Catheter (2017), cited by 3
- K172790: ER-REBOA Catheter (2017), cited by 3
- K200459: pREBOA-PRO Catheter (2020), cited by 1

## Recent decisions
- K243795: pREBOA-PRO Catheter (Sep 5, 2025)
- K200459: pREBOA-PRO Catheter (Jun 3, 2020)
- K193440: ER-REBOA PLUS Catheter (Jan 9, 2020)
- K172790: ER-REBOA Catheter (Nov 8, 2017)
- K170411: ER-REBOA Catheter (Apr 4, 2017)

Source page: https://510kreport.com/company/prytime-medical-devices