Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FER — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
82 daysmedian FDA review time
304 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anos | Haemoband Surgical, Ltd. | 2025-10-09 | 219 | 0 |
| K242668 | Gastro Concepts Air Assist | Gastro Concepts, LLC | 2024-12-13 | 99 | 0 |
| K230439 | WellCare Anoscope | Well Care (Wuhan) Medical Technology Co., Ltd. | 2023-12-22 | 304 | 0 |
| K200021 | Applied Medical Anoscope | Applied Medical Resources | 2021-01-06 | 366 | 0 |
| K171701 | GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | 2017-07-20 | 42 | 0 |
| K133393 | GELPOINT PATH TRANSANAL ACCESS PLATFORM | Applied Medical Resources Corp. | 2014-01-02 | 58 | 0 |
| K133687 | THD N-ANO ANOSCOPE | Thd Spa | 2013-12-11 | 9 | 0 |
| K121604 | ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT | Obp Corporation | 2012-07-27 | 56 | 0 |
| K121135 | THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT- | Thd Spa | 2012-06-01 | 49 | 0 |
| K110792 | GELPOINT PATH | Applied Medical Resources Corp. | 2011-05-23 | 63 | 0 |
| K103647 | THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES | Thd Spa | 2011-03-01 | 78 | 0 |
| K093896 | ETHICON ENDO SURGERY SLOTTED ANOSCOPE | Ethicon Endo-Surgery, Inc. | 2010-03-25 | 97 | 0 |
| K091490 | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES | Thd Spa | 2009-06-11 | 22 | 0 |
| K090432 | HEMORPEX SYSTEM | Angiologica B. M. Srl | 2009-05-29 | 99 | 0 |
| K080132 | THD DISPOSABLE ANOSCOPE/PROCTOSCOPE | Thd Spa | 2008-04-09 | 82 | 0 |
| K070913 | SELF-LIGHT DISPOSABLE ANOSCOPE | Sapimed S.P.A. | 2007-08-10 | 130 | 0 |
| K060623 | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW | Cook Ireland, Ltd. | 2006-09-06 | 182 | 0 |
| K020702 | O'REGAN DISPOSABLE ANOSCOPE | Canadian Theatre Products , Ltd. | 2002-03-29 | 25 | 0 |
| K011825 | RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE | Sightline Technologies , Ltd. | 2001-07-11 | 30 | 0 |
| K994130 | RECTOSIGHT RS 300-04 | Sightline Technologies , Ltd. | 2000-06-30 | 206 | 0 |
| K993738 | DISPOS-A-SCOPE | Dispos-A-Scope | 2000-01-06 | 63 | 0 |
| K921291 | INMAN MEDICAL PACKING STRIP | Inman Medical Corp. | 1993-01-21 | 316 | 0 |
| K881469 | ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL | Baxter Healthcare Corp | 1988-09-12 | 158 | 0 |
| K861017 | GALENICA'S DISPOSABLE ANOSCOPES | Galenica Enterprises, Inc. | 1986-06-13 | 87 | 0 |
| K822085 | PRO-SCOPE | Exitec, Inc. | 1983-05-09 | 300 | 0 |
| K810227 | MODEL #53110 DISPOSABLE ANOSCOPE | Welch Allyn, Inc. | 1981-02-19 | 23 | 0 |
| K770906 | ANOSCOPE, OPTIC, FIBER | Welch Allyn, Inc. | 1977-06-01 | 14 | 0 |
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