510(k) Report

FDA applicant

Prytime Medical Devices, Inc.

Boerne, TX5 decisions2017–20251 recall

FDA records 5 decisions for Prytime Medical Devices, Inc. (Boerne, TX) from 2017 to 2025: 5 510(k) clearances. All are in product code MJN (Catheter, Intravascular Occluding, Temporary). Since 2016 its 510(k)s took a median of 54 days from receipt to decision, against 59 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Prytime Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017: 22020: 22025: 1
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2017high 1 (2020) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Prytime Medical Devices, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Prytime Medical Devices, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MJNCatheter, Intravascular Occluding, Temporary5decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 54 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 59 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170411ER-REBOA CatheterPrytime Medical Devices, Inc. · 20173cite it
  • K172790ER-REBOA CatheterPrytime Medical Devices, Inc. · 20173cite it
  • K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 20201cites it

What has FDA decided for it lately?

  • K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2025
  • K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2020
  • K193440ER-REBOA PLUS CatheterPrytime Medical Devices, Inc. · 20201 recall
  • K172790ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
  • K170411ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017

All 5 as Prytime Medical Devices, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K193440PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel…Oct 29, 2020Class II