Facility

Prytime Medical Devices, Inc.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3026788751
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	12 Upper Balcones Rd. Boerne, TX, US 78006
Registration status	Active · expires 2026
Parent company	Prytime Medical Devices, Inc. (owner-operator 10050783)
Brand names	pREBOA-PRO Catheter

Activity by year

Recalls (2)

Devices registered here (3)

Catheter, Percutaneous
Product code DQY (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1250
Catheter, Intravascular, Diagnostic
Product code DQO (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1200
Catheter, Intravascular Occluding, Temporary
Product code MJN (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4450

Recalls & enforcement

Class IITerminated2020-12-14
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 intr…
Class IITerminated2020-10-29
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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Prytime Medical Devices, Inc. (FEI 3026788751) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3026788751-prytime-medical-devices-inc/

Not open yet

Alerts for Prytime Medical Devices, Inc.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.