FDA product code NLH: Catheter, Recording, Electrode, Reprocessed
NLH is the FDA product code for catheter, recording, electrode, reprocessed. It is a Class II device, regulated under 21 CFR 870.1220 and reviewed by the Cardiovascular panel. FDA has cleared 70 510(k) submissions under NLH, 10 in the last five years, from 10 different applicants. The average 510(k) review took 156 days (median 130); 135 days on average over the last three years. FDA has posted 48 recalls for NLH devices, 37 initiated in the last five years.
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).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Recording, Electrode, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.1220 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for NLH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 185 |
| 2018 | 4 | 120 |
| 2019 | 4 | 208 |
| 2020 | 2 | 82 |
| 2021 | 2 | 140 |
| 2022 | 1 | 40 |
| 2023 | 1 | 414 |
| 2024 | 6 | 151 |
| 2025 | 2 | 119 |
Compare with all 510(k) review times · Search every NLH clearance
Top NLH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovative Health, LLC | 23 | 2022-08-06 |
| Sterilmed, Inc. | 10 | 2024-10-11 |
| Alliance Medical Corp. | 9 | 2006-08-31 |
| Vanguard Medical Concepts, Inc. | 9 | 2005-06-06 |
| Surgical Instrument Service and Savings, Inc. | 7 | 2025-11-26 |
5 more applicants have NLH clearances. See the full list in Caduvo.
Most recent NLH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252405 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | 2025-11-26 | 118 |
| K250772 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | 2025-07-11 | 120 |
| K242225 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | 2024-11-29 | 123 |
| K241224 | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) | 2024-11-15 | 197 |
| K240826 | Sterilmed, Inc. | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | 2024-10-11 | 199 |
Recalls for NLH devices
48 product recalls in 16 recall events; 37 initiated in the last five years and 37 still open. Most recent: 2026-05-15.
| Year | Recalls |
|---|---|
| 2018 | 5 |
| 2024 | 1 |
| 2025 | 9 |
| 2026 | 27 |
Frequently asked questions
What is FDA product code NLH?
NLH is the FDA product code for catheter, recording, electrode, reprocessed. It is a Class II device, regulated under 21 CFR 870.1220 and reviewed by the Cardiovascular panel.
What device class is NLH?
Class II, regulation 21 CFR 870.1220. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLH?
Across 70 cleared submissions the average was 156 days from receipt to decision (median 130).
Which companies have the most NLH clearances?
Innovative Health, LLC (23); Sterilmed, Inc. (10); Alliance Medical Corp. (9); Vanguard Medical Concepts, Inc. (9); Surgical Instrument Service and Savings, Inc. (7).
Have NLH devices been recalled?
Yes: 48 product recalls across 16 recall events; the most recent began 2026-05-15.
Next steps
- Run an FDA pathway report with predicate devices for product code NLH
- Run a recall and safety report across every NLH manufacturer
- Watch product code NLH for new clearances and recalls
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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