Applied Medical Resources: FDA clearances and approvals
Applied Medical Resources has 115 FDA 510(k) clearances (first 1992, latest 2026), across 30 product codes in 6 review panels. Median 510(k) review time: 88 days. Since 2017 its median was 71 days, against 112 days for all cleared 510(k)s in the same product codes. openFDA lists 75 product recalls by a recalling firm named Applied Medical Resources.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 462 |
| 2014 | 4 | 107 |
| 2015 | 3 | 122 |
| 2016 | 4 | 232 |
| 2017 | 2 | 52 |
| 2018 | 5 | 50 |
| 2019 | 3 | 115 |
| 2020 | 2 | 30 |
| 2021 | 2 | 388 |
| 2022 | 3 | 165 |
| 2023 | 1 | 44 |
| 2024 | 0 | — |
| 2025 | 4 | 90 |
| 2026 | 2 | 66 |
Review time against the same product codes
Since 2017, Applied Medical Resources's cleared 510(k)s took a median 71 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 26 | 26 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 21 | 21 |
| HET | Laparoscope, Gynecologic (And Accessories) | 7 | 7 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | 7 | 7 |
| FAD | Stent, Ureteral | 5 | 5 |
| DXE | Catheter, Embolectomy | 4 | 4 |
| EYB | Catheter, Ureteral, Gastro-Urology | 4 | 4 |
| FER | Anoscope And Accessories | 4 | 4 |
| FZP | Clip, Implantable | 4 | 4 |
| DYB | Introducer, Catheter | 3 | 3 |
Plus 20 more product codes.
Review panels
- General and Plastic Surgery (62)
- Gastroenterology and Urology (23)
- Cardiovascular (14)
- Obstetrics and Gynecology (12)
- General Hospital (3)
- Anesthesiology (1)
Most recent Applied Medical Resources 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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) | KGW | 2026-04-24 | 30 |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | KGW | 2026-02-23 | 102 |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) | GEI | 2025-11-04 | 68 |
| K252442 | Kii Structural Balloon Access System | GCJ | 2025-10-31 | 88 |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | GEI | 2025-10-31 | 91 |
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | HEW | 2025-10-02 | 367 |
| K232880 | Inzii Ripstop Redeployable Retrieval System | GCJ | 2023-11-01 | 44 |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | GEI | 2022-10-14 | 74 |
| K220969 | GelPOINT V-Path Vaginal Access System | MOK | 2022-09-16 | 165 |
| K211043 | Alexis Contained Extraction System | GCJ | 2022-03-31 | 357 |
105 earlier clearances. See the full list in Caduvo.
Recalls
75 product recalls in 24 recall events; 3 initiated in the last five years. Most recent: 2025-12-11.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Applied Medical Resources have?
Applied Medical Resources has 115 FDA 510(k) clearances (first 1992, latest 2026), across 30 product codes in 6 review panels.
How long does FDA take to clear Applied Medical Resources's 510(k)s?
The median time from FDA receipt to decision across Applied Medical Resources's cleared 510(k)s is 88 days. Since 2017: 71 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Applied Medical Resources make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 26); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 21); HET (Laparoscope, Gynecologic (And Accessories), 7).
Has Applied Medical Resources had device recalls?
openFDA lists 75 product recalls in 24 recall events by a recalling firm whose name matches Applied Medical Resources; the most recent began 2025-12-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 115 Applied Medical Resources clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Applied Medical Resources's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.