Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Medical Resources Corp. — Predicate Candidate Screening
45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
204 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp. | 2025-11-04 | 68 | 0 |
| K252442 | Kii Structural Balloon Access System | Applied Medical Resources Corp. | 2025-10-31 | 88 | 0 |
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperit | Applied Medical Resources Corp. | 2025-10-02 | 367 | 0 |
| K201212 | Voyant Open Fusion Device | Applied Medical Resources Corp. | 2020-06-05 | 31 | 0 |
| K200598 | Voyant Maryland Fusion Device | Applied Medical Resources Corp. | 2020-04-08 | 30 | 0 |
| K193292 | Voyant 5mm Fusion Device, Voyant Maryland Fusion Device | Applied Medical Resources Corp. | 2019-12-20 | 23 | 0 |
| K191294 | Transvaginal Access Platform | Applied Medical Resources Corp. | 2019-09-06 | 115 | 0 |
| K182653 | Voyant Maryland Fusion Device | Applied Medical Resources Corp. | 2018-11-14 | 50 | 0 |
| K182244 | Voyant Electrosurgical Generator | Applied Medical Resources Corp. | 2018-10-11 | 52 | 0 |
| K182024 | Dissecting Balloon System | Applied Medical Resources Corp. | 2018-08-30 | 31 | 0 |
| K171701 | GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | 2017-07-20 | 42 | 0 |
| K132300 | EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL | Applied Medical Resources Corp. | 2014-01-24 | 184 | 0 |
| K133393 | GELPOINT PATH TRANSANAL ACCESS PLATFORM | Applied Medical Resources Corp. | 2014-01-02 | 58 | 0 |
| K113268 | ALEXIS O WOUND PROTECTOR/RETRACTOR | Applied Medical Resources Corp. | 2013-02-08 | 462 | 0 |
| K110792 | GELPOINT PATH | Applied Medical Resources Corp. | 2011-05-23 | 63 | 0 |
| K103282 | LAPAROSCOPIC DISSECTOR | Applied Medical Resources Corp. | 2010-11-16 | 11 | 0 |
| K100120 | ALEXIS ORTHOPAEDIC WOUND RETRACTOR | Applied Medical Resources Corp. | 2010-04-02 | 77 | 0 |
| K093296 | ALEXIS LAPAROSCOPIC SYSTEM | Applied Medical Resources Corp. | 2009-11-05 | 15 | 0 |
| K090275 | GELPORT SINGLE INCISION ACCESS SYSTEM | Applied Medical Resources Corp. | 2009-02-18 | 14 | 0 |
| K083638 | FIXATION TROCARS | Applied Medical Resources Corp. | 2008-12-23 | 14 | 0 |
| K072674 | KII TROCAR SYSTEM | Applied Medical Resources Corp. | 2007-10-05 | 14 | 2 |
| K063658 | INTRAVASCULAR INTRODUCER SYSTEM | Applied Medical Resources Corp. | 2007-09-12 | 278 | 0 |
| K062169 | APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS | Applied Medical Resources Corp. | 2006-08-24 | 24 | 0 |
| K060629 | GELPORT BLUNT TIP TROCAR SYSTEM | Applied Medical Resources Corp. | 2006-04-07 | 29 | 0 |
| K060673 | PEDIATRIC URETERAL STENT | Applied Medical Resources Corp. | 2006-03-29 | 15 | 6 |
| K060534 | INTUITIVE SURGICAL SEAL | Applied Medical Resources Corp. | 2006-03-13 | 13 | 0 |
| K060096 | MODULAR TROCAR SYSTEM | Applied Medical Resources Corp. | 2006-01-24 | 11 | 7 |
| K060051 | SPECIMEN RETRIEVAL SYSTEM | Applied Medical Resources Corp. | 2006-01-19 | 13 | 1 |
| K041506 | INTRAVASCULAR ACCESS INTRODUCER SHEATH | Applied Medical Resources Corp. | 2004-10-15 | 130 | 0 |
| K040760 | MODIFICATION TO URETERAL STENT | Applied Medical Resources Corp. | 2004-10-15 | 204 | 6 |
| K041795 | MODIFICATION TO OPTICAL SEPARATOR SYSTEM | Applied Medical Resources Corp. | 2004-09-14 | 74 | 0 |
| K041711 | ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C | Applied Medical Resources Corp. | 2004-08-26 | 64 | 0 |
| K040295 | APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS | Applied Medical Resources Corp. | 2004-03-12 | 32 | 0 |
| K033024 | MODIFICATION TO SUTURE CLINCH | Applied Medical Resources Corp. | 2003-10-24 | 28 | 0 |
| K031889 | ALEXIS WOUND RETRACTOR | Applied Medical Resources Corp. | 2003-09-22 | 96 | 0 |
| K030642 | DEFLECTING URETERAL ACCESS SHEATH | Applied Medical Resources Corp. | 2003-05-23 | 84 | 0 |
| K020577 | APPLIED URETERAL CATHETER | Applied Medical Resources Corp. | 2002-05-22 | 90 | 0 |
| K020435 | WOUND PROTECTOR/RETRACTOR | Applied Medical Resources Corp. | 2002-04-15 | 66 | 0 |
| K014047 | APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE | Applied Medical Resources Corp. | 2002-02-28 | 83 | 0 |
| K012884 | DILATING TIP OBTURATOR | Applied Medical Resources Corp. | 2002-01-17 | 142 | 7 |
| K012968 | APPLIED ACCESS SEAL | Applied Medical Resources Corp. | 2001-12-03 | 90 | 0 |
| K010006 | DRAINAGE CATHETER OR FOLEY CATHETER | Applied Medical Resources Corp. | 2001-07-25 | 204 | 0 |
| K011264 | MESH URETERAL STENT | Applied Medical Resources Corp. | 2001-07-17 | 83 | 0 |
| K003871 | LAPAROSCOPIC HAND PORT | Applied Medical Resources Corp. | 2001-05-31 | 167 | 1 |
| K011236 | MODIFICATION TO IMPLANTABLE CLIP | Applied Medical Resources Corp. | 2001-05-14 | 21 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda