FDA product code FRN: Pump, Infusion

FRN is the FDA product code for pump, infusion. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 849 510(k) submissions under FRN, 28 in the last five years, from 269 different applicants. The average 510(k) review took 126 days (median 83); 228 days on average over the last three years. FDA has posted 721 recalls for FRN devices, 134 initiated in the last five years.

Classification

Field	Value
Device name	Pump, Infusion
Device class	Class II
Regulation	21 CFR 880.5725
Review panel	HO — General Hospital
Medical specialty	General Hospital
Premarket route	510(k)

510(k) clearances per year for FRN

Year	Clearances	Avg. review days
2017	3	312
2018	3	269
2019	2	142
2020	1	412
2021	2	446
2022	6	264
2023	7	306
2024	5	297
2025	8	158
2026	2	228

Compare with all 510(k) review times · Search every FRN clearance

Top FRN applicants

Applicant	Clearances	Latest
Abbott Laboratories	66	2004-06-30
Baxter Healthcare Corp	39	2007-04-16
Y	26	1993-10-12
Travenol Laboratories, S.A.	23	1988-02-22
Imed Corp.	22	1996-11-21

264 more applicants have FRN clearances. See the full list in Caduvo.

Most recent FRN clearances

510(k)	Applicant	Device	Decision date	Review days
K253703	Deka R&D Corp	RemunityPRO+ Pump for Remodulin® (treprostinil) Injection	2026-07-24	242
K252015	Koru Medical Systems, Inc.	FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing	2026-01-28	215
K251636	Baxter Healthcare Corporation	Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)	2025-07-28	60
K251640	Baxter Healthcare Corporation	SIGMA Spectrum Infusion Pump with Master Drug Library	2025-07-28	60
K242752	Iradimed Corporation	MRidium 3870 MRI Infusion Pump System (3870)	2025-05-28	258

Recalls for FRN devices

721 product recalls in 346 recall events; 134 initiated in the last five years and 152 still open. Most recent: 2026-08-11.

Year	Recalls
2017	21
2018	11
2019	23
2020	43
2021	15
2022	6
2023	36
2024	36
2025	40
2026	13

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

A4220 — Refill kit for implantable infusion pump
E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
E0783 — Infusion pump system, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.)

Frequently asked questions

What is FDA product code FRN?

FRN is the FDA product code for pump, infusion. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.

What device class is FRN?

Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).

How long does a 510(k) take for product code FRN?

Across 849 cleared submissions the average was 126 days from receipt to decision (median 83).

Which companies have the most FRN clearances?

Abbott Laboratories (66); Baxter Healthcare Corp (39); Y (26); Travenol Laboratories, S.A. (23); Imed Corp. (22).

Have FRN devices been recalled?

Yes: 721 product recalls across 346 recall events; the most recent began 2026-08-11.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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