# Applied Medical Resources

- Location (FDA's records): Rancho Santa, CA
- FDA decisions: 115 (1992–2026): 115 510(k) clearances
- Names in FDA's records: Applied Medical Resources (58); Applied Medical Resources Corp. (45); Applied Medical Resources Corporation (12)
- Product codes: GCJ (26), GEI (21), KGW (7), HET (7), FAD (5), FZP (4), FER (4), DXE (4), EYB (4), GBZ (3), LYK (3), FED (3)
- 510(k) review time since 2016: median 67 days, against 107 for FDA's reviews in the same codes and years (14 of 20 faster)
- Predicates its devices cite: 87 (52 its own); citations of its devices by later devices: 106 (52 its own)
- Recalls linked to its devices: 32 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Applied Vascular Devices, Inc.: 5 (https://510kreport.com/company/applied-vascular-devices)
- Ethicon Endo-Surgery, Inc.: 4 (https://510kreport.com/company/ethicon-endo-surgery)
- Covidien, Formerly Valleylab, A Division of Tyco H: 3 (https://510kreport.com/company/covidien-formerly-valleylab-a-division-of-tyco-h)
- Cook Urological, Inc.: 3 (https://510kreport.com/company/cook-urological)
- Origin Medsystems, Inc.: 3 (https://510kreport.com/company/origin-medsystems)
- Medical Creative Technologies, Inc.: 2 (https://510kreport.com/company/medical-creative-technologies)
- Sapimed S.P.A.: 2 (https://510kreport.com/company/sapimed)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)

## Firms that cite its devices most
- Sterilmed, Inc.: 6 (https://510kreport.com/company/sterilmed)
- Ascent Healthcare Solutions: 4 (https://510kreport.com/company/ascent-healthcare-solutions)
- Applied Medical: 3 (https://510kreport.com/company/applied-medical)
- Cook Urological, Inc.: 3 (https://510kreport.com/company/cook-urological)
- Unimax Medical Systems, Inc.: 3 (https://510kreport.com/company/unimax-medical-systems)
- Advanced Surgical Concepts: 2 (https://510kreport.com/company/advanced-surgical-concepts)
- Advanced Medical Innovations, Inc.: 2 (https://510kreport.com/company/advanced-medical-innovations)
- Richard Wolf Medical Instruments Corp.: 2 (https://510kreport.com/company/richard-wolf-medical-instruments)

## Its most-cited devices
- K060096: Modular Trocar System (2006), cited by 6
- K041711: Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304 (2004), cited by 6
- K060051: Specimen Retrieval System (2006), cited by 4
- K032889: Optical Separator (2003), cited by 4
- K083638: Fixation Trocars (2008), cited by 3
- K110792: Gelpoint Path (2011), cited by 3

## Recent decisions
- K260982: Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) (Apr 24, 2026)
- K253531: Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) (Feb 23, 2026)
- K252740: Voyant® Open Fusion Device (EB240/Open Fusion) (Nov 4, 2025)
- K252412: Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) (Oct 31, 2025)
- K252442: Kii Structural Balloon Access System (Oct 31, 2025)
- K243152: GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (Oct 2, 2025)
- K232880: Inzii Ripstop Redeployable Retrieval System (Nov 1, 2023)
- K222284: Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) (Oct 14, 2022)

Source page: https://510kreport.com/company/applied-medical-resources