FIRClass II

Pump, Blood, Extra-Luminal

21 CFR 876.5820 / Gastroenterology, Urology

FIR is the FDA product code for Pump, Blood, Extra-Luminal, a class II device type, regulated under 21 CFR 876.5820. As of 2026-09-10, FDA records hold 7 510(k) clearances under this code, the most recent dated 1996-06-14, and 3 recalls.

Classification record

Product code: FIR
Device name: Pump, Blood, Extra-Luminal
Regulation: 21 CFR 876.5820
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 7
Ingested recalls: 3

Clearances, product code FIR

By decision year

7 clearances under product code FIR with a decision year between 1976 and 1996, 1983 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code FIR by decision year
Year	Clearances
1976	1
1977	1
1978	1
1982	1
1983	2
1996	1

Applicants with the most clearances

Product code FIR

Applicants holding the most 510(k) clearances under product code FIR
Applicant	Clearances
3M Health Care, Sarns	1
Apheresis Technologies, Inc.	1
Cryosan, Inc.	1
Dws, Inc.	1
Extracorporeal Medical Specialities, Inc.	1
Parker Hannifin Corp.	1
Renal Systems, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FIR.