Prytime Medical Devices, Inc.
Lakewood, CO, US
PRYTIME MEDICAL DEVICES, INC. appears in FDA device records in Lakewood, CO. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Prytime Medical Devices, Inc. between 2017 and 2025. The busiest year on record is 2017, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 2 |
| 2020 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243795 | pREBOA-PRO Catheter | MJN | Substantially Equivalent | |
| K200459 | pREBOA-PRO Catheter | MJN | Substantially Equivalent | |
| K193440 | ER-REBOA PLUS Catheter | MJN | Substantially Equivalent | |
| K172790 | ER-REBOA Catheter | MJN | Substantially Equivalent | |
| K170411 | ER-REBOA Catheter | MJN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012279212 | 3012279212 | PRYTIME MEDICAL DEVICES, INC. | 575 Union Blvd Suite 107, Lakewood, CO 80228 US | 2026 | |
| 3026788751 | 3026788751 | Prytime Medical Devices, Inc. | 12 Upper Balcones Rd., Boerne, TX 78006 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0959-2021 | PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1 | There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass through the access needle to facilitate insertion of an introducer sheath and could therefore cause procedure delay or injury. | Class II | Terminated | |
| Z-0716-2021 | PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage. | There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain