FDA product code LZH: Pump, Infusion, Enteral

LZH is the FDA product code for pump, infusion, enteral. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 34 510(k) submissions under LZH, 4 in the last five years, from 25 different applicants. The average 510(k) review took 175 days (median 166); 154 days on average over the last three years. FDA has posted 24 recalls for LZH devices.

Classification

Field	Value
Device name	Pump, Infusion, Enteral
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 LZH

Year	Clearances	Avg. review days
2020	1	259
2022	2	244
2023	1	90
2026	1	154

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

Top LZH applicants

Applicant	Clearances	Latest
Covidien	3	2016-07-06
Sandoz Nutrition	3	1995-02-01
Amsino International, Inc.	2	2022-11-10
Zevex Intl., Inc.	2	2003-07-09
Ross Product Div. Abbott Laboratories	2	2003-05-20

20 more applicants have LZH clearances. See the full list in Caduvo.

Most recent LZH clearances

510(k)	Applicant	Device	Decision date	Review days
K253558	Luminoah	Luminoah FLOW Enteral Nutrition System	2026-04-20	154
K232205	Vesco Medical, LLC	Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set	2023-10-23	90
K221603	Cardinal Health, LLC	Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI	2022-12-20	201
K220230	Amsino International, Inc.	AMSure Enteral Feeding Pump	2022-11-10	287
K200051	Amsino International, Inc.	PUGGLE Enteral Feeding Pump and Feeding Set	2020-09-25	259

Recalls for LZH devices

24 product recalls in 14 recall events; 0 initiated in the last five years and 8 still open. Most recent: 2021-01-19.

Year	Recalls
2019	6
2020	2
2021	1

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

Frequently asked questions

What is FDA product code LZH?

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

What device class is LZH?

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

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

Across 34 cleared submissions the average was 175 days from receipt to decision (median 166).

Which companies have the most LZH clearances?

Covidien (3); Sandoz Nutrition (3); Amsino International, Inc. (2); Zevex Intl., Inc. (2); Ross Product Div. Abbott Laboratories (2).

Have LZH devices been recalled?

Yes: 24 product recalls across 14 recall events; the most recent began 2021-01-19.

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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