Sterilmed, Inc.: FDA filings under this applicant name
FDA lists 65 510(k) clearances under the applicant name “Sterilmed, Inc.” (first 2001, latest 2026), across 25 product codes in 7 review panels. Median 510(k) review time under this name: 157 days. Since 2017 the median was 199 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 112 |
| 2013 | 1 | 115 |
| 2014 | 2 | 190 |
| 2015 | 3 | 155 |
| 2016 | 5 | 168 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 3 | 236 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 199 |
| 2025 | 0 | — |
| 2026 | 1 | 189 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sterilmed, Inc. took a median 199 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | 10 | 10 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 8 | 8 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 7 | 7 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 6 | 6 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 6 | 6 |
| NLF | Oximeter, Reprocessed | 4 | 4 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| JOW | Sleeve, Limb, Compressible | 2 | 2 |
| NLL | Staple, Implantable, Reprocessed | 2 | 2 |
| NMF | Clamp, Vascular, Reprocessed | 2 | 2 |
Plus 15 more product codes.
Review panels
- Cardiovascular (23)
- General and Plastic Surgery (20)
- Gastroenterology and Urology (11)
- Orthopedic (5)
- Anesthesiology (4)
- Ear, Nose and Throat (1)
- Ophthalmic (1)
Most recent Sterilmed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | OWQ | 2026-06-29 | 189 |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | NLH | 2024-10-11 | 199 |
| K190478 | Reprocessed ViewFlex Xtra ICE Catheter | OWQ | 2019-11-14 | 260 |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | NLQ | 2019-08-15 | 157 |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | NLQ | 2019-04-15 | 236 |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | OWQ | 2016-11-21 | 154 |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) | NUJ | 2016-09-20 | 155 |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | NLH | 2016-06-23 | 253 |
| K152090 | Reprocessed Steerable Introducer | PNE | 2016-03-23 | 240 |
| K152134 | Reprocessed Vessel Sealer | NUJ | 2016-01-15 | 168 |
55 earlier clearances. See the full list in Caduvo.
Recalls
41 product recalls in 9 recall events; 2 initiated in the last five years. Most recent: 2025-10-08.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sterilmed Inc. (Johnson and Johnson) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sterilmed, Inc.?
FDA lists 65 510(k) clearances under the applicant name “Sterilmed, Inc.” (first 2001, latest 2026), across 25 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sterilmed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sterilmed, Inc. is 157 days. Since 2017: 199 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sterilmed, Inc.?
The most frequent FDA product codes under this applicant name are NLH (Catheter, Recording, Electrode, Reprocessed, 10); NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments, 8); NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, 7).
Next steps
- See all 65 Sterilmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NLH, Sterilmed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.