Data / Medical devices / United States / Prytime Medical Devices, Inc.

Prytime Medical Devices, Inc.: FDA-registered device maker in Boerne, TX, United States, 3 510(k) clearances

Name: Prytime Medical Devices, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Prytime Medical Devices, Inc. is registered with the FDA (registration 3026788751) in Boerne, TX, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 5, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3026788751
Address: 12 Upper Balcones Rd. Suite 300, Boerne, TX, United States, 78006
Owner or operator: Prytime Medical Devices, Inc. (10050783)
Roles: Complaint file establishment, Specification developer
First device listed: May 3, 2017
Registered through: 2026
Brand names listed: ER-REBOA 2 Catheter, ER-REBOA PLUS Catheter, REBOA Catheter Compass Convenience Set, REBOA Catheter Convenience Set, pREBOA-PRO Catheter

Devices it lists

Device	Product code	Class	Role	Source
Catheter Introducer Kit	OFC	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Intravascular Occluding, Temporary	MJN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 5, 2025	K243795	pREBOA-PRO Catheter	MJN	Substantially Equivalent	Prytime Medical Devices, Inc.	accessdata.fda.gov
June 3, 2020	K200459	pREBOA-PRO Catheter	MJN	Substantially Equivalent	Prytime Medical Devices, Inc.	accessdata.fda.gov
January 9, 2020	K193440	ER-REBOA PLUS Catheter	MJN	Substantially Equivalent	Prytime Medical Devices, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 14, 2020	87099	Class II	Terminated	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., PREFIL	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.	accessdata.fda.gov
October 29, 2020	86797	Class II	Terminated	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	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.	accessdata.fda.gov

Compare with other makers

Updated September 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.