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Prytime Medical Devices Inc.

United States·US-MF-000008225

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Prytime Medical Devices, Inc.	KT1835C	FDA UDI	Class II	Active
Prytime Medical Devices, Inc.	PRP7226PRO	FDA UDI	Class II	Active
ER-REBOA Catheter	ER7232A	FDA UDI	Class II	Active
Prytime Medical Devices, Inc.	PRP7226M	FDA UDI	Class II	Active
Prytime Medical Devices, Inc.	KT1835M	FDA UDI	Class II	Active
ER-REBOA Catheter	K172790	FDA 510(k)	Class II	Active
ER-REBOA Catheter	K170411	FDA 510(k)	Class II	Active
pREBOA-PRO Catheter	K200459	FDA 510(k)	Class II	Active
ER-REBOA PLUS Catheter	K193440	FDA 510(k)	Class II	Active
pREBOA-PRO Catheter	K243795	FDA 510(k)	Class II	Active
REBOA™ Catheter Convenience Kit (EU)	KT1835E	EUDAMED	Class I	Active
ER-REBOA™ PLUS Catheter	ER7232PLUS-EU	EUDAMEDFDA UDI	Class III	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 14, 2020	Z-0959-2021	—	terminated	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.
Oct 29, 2020	Z-0716-2021	—	terminated	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.

Establishments registered with the FDA under this company group, matched by name.