NLHClass II

Catheter, Recording, Electrode, Reprocessed

21 CFR 870.1220 / Cardiovascular

NLH is the FDA product code for Catheter, Recording, Electrode, Reprocessed, a class II device type, regulated under 21 CFR 870.1220. FDA's definition for this code reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". As of 2026-09-10, FDA records hold 70 510(k) clearances under this code, the most recent dated 2025-11-26, and 48 recalls.

Classification record

Product code: NLH
Device name: Catheter, Recording, Electrode, Reprocessed
FDA definition: Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation: 21 CFR 870.1220
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 70
Ingested recalls: 48

Clearances, product code NLH

By decision year

70 clearances under product code NLH with a decision year between 2002 and 2025, 2016 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code NLH by decision year
Year	Clearances
2002	7
2003	5
2005	10
2006	1
2008	2
2009	1
2010	3
2011	2
2012	1
2015	1
2016	11
2017	4
2018	4
2019	4
2020	2
2021	2
2022	1
2023	1
2024	6
2025	2

Applicants with the most clearances

Product code NLH

Applicants holding the most 510(k) clearances under product code NLH
Applicant	Clearances
Innovative Health, LLC.	24
Stryker Sustainability Solutions	17
Alliance Medical Corp.	10
Sterilmed Inc	10
Medline ReNewal	7
Surgical Instrument Service and Savings Inc.(Dba Medline Ren	2

Companies listing this code with FDA

Companies whose registered establishments list this code