# Sterilmed, Inc.

- Location (FDA's records): Maple Grove, MN
- FDA decisions: 65 (2001–2026): 65 510(k) clearances
- Product codes: NLH (10), NLQ (8), NUJ (7), OWQ (6), NLM (6), NLF (4), KTT (3), JOW (2), NLL (2), NMF (2), PNE (1), ERL (1)
- 510(k) review time since 2016: median 199 days, against 155 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 111 (5 its own); citations of its devices by later devices: 8 (5 its own)
- Recalls linked to its devices: 24 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ethicon Endo-Surgery, Inc.: 13 (https://510kreport.com/company/ethicon-endo-surgery)
- Biosense Webster, Inc.: 10 (https://510kreport.com/company/biosense-webster)
- Irvine Biomedical, Inc.: 8 (https://510kreport.com/company/irvine-biomedical)
- Masimo Corporation: 7 (https://510kreport.com/company/masimo)
- Applied Medical Resources: 6 (https://510kreport.com/company/applied-medical-resources)
- Ultracision, Inc.: 4 (https://510kreport.com/company/ultracision)
- Boston Scientific Corp: 4 (https://510kreport.com/company/boston-scientific)
- United States Surgical, A Division of Tyco Healthc: 3 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)

## Firms that cite its devices most
- Surgical Instruments Service and Savings, Inc.: 1 (https://510kreport.com/company/surgical-instruments-service-and-savings)
- Medisiss: 1 (https://510kreport.com/company/medisiss)
- Suretek Medical: 1 (https://510kreport.com/company/suretek-medical)

## Its most-cited devices
- K012677: Reprocessed Pulse Oximeter Sensors (2003), cited by 1
- K012597: Sterilmed Reprocessed Compression Sleeves (2002), cited by 1
- K043592: Reprocessed Endoscopic Trocar (2005), cited by 1
- K123096: Reprocessed Vessel Sealer (2013), cited by 1
- K012598: Reprocessed Laparoscopic Electric Instuments (2001), cited by 1
- K110076: Reprocessed 3D Diagnostic Ultrasound Catheter (2011), cited by 1

## Recent decisions
- 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) (Jun 29, 2026)
- K240826: Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (Oct 11, 2024)
- K190478: Reprocessed ViewFlex™ Xtra ICE Catheter (Nov 14, 2019)
- K190610: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (Aug 15, 2019)
- K182272: Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (Apr 15, 2019)
- K161700: SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters (Nov 21, 2016)
- K161086: Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) (Sep 20, 2016)
- K153006: Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter (Jun 23, 2016)

Source page: https://510kreport.com/company/sterilmed