Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Prytime Medical Devices with 5 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Sep 5, 2025: pREBOA-PRO Catheter.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 5, 2025 | pREBOA-PRO CatheterK243795 · MJN | 510(k) clearances |
| Dec 14, 2020 | PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERClass II · There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If | Device recalls |
| Oct 29, 2020 | PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UClass II · There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a p | Device recalls |
| Jun 3, 2020 | pREBOA-PRO CatheterK200459 · MJN | 510(k) clearances |
| Jan 9, 2020 | ER-REBOA PLUS CatheterK193440 · MJN | 510(k) clearances |
| Nov 8, 2017 | ER-REBOA CatheterK172790 · MJN | 510(k) clearances |
| Apr 4, 2017 | ER-REBOA CatheterK170411 · MJN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
