Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FHN — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
260 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213223 | Multi-Band Ligator | Beijing Zksk Technology Co., Ltd. | 2022-06-06 | 250 | 0 |
| K172985 | Ligation Device | Leo Medical Co., Ltd. | 2018-06-14 | 260 | 0 |
| K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | 2015-06-12 | 85 | 0 |
| K131282 | NEXUS HEMORRHOID LIGATOR | Inx Medical | 2013-07-11 | 66 | 0 |
| K093497 | THD BANDY | Thd Spa | 2010-07-15 | 245 | 0 |
| K091519 | HAEMOBAND MULTI-LIGATOR | Haemoband Surgical, Ltd. | 2009-07-28 | 67 | 0 |
| K070881 | LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 | Sapimed S.P.A. | 2007-09-26 | 180 | 0 |
| K020824 | SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW S | Boston Scientific Corp | 2002-04-12 | 29 | 0 |
| K020526 | MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR | Don Wilson/Wilson-Cook Medical, Inc. | 2002-03-19 | 28 | 0 |
| K001236 | RIZA BAND STRETCHER (RBS)-60000 | R-Med, Inc. | 2000-07-17 | 90 | 0 |
| K000297 | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCH | Erchinger Medizintecnik | 2000-04-24 | 84 | 0 |
| K000397 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 | Boston Scientific Corp | 2000-03-07 | 29 | 0 |
| K981669 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR | Boston Scientific Corp | 1998-06-04 | 23 | 0 |
| K974018 | WILSON-COOK 10 SHOT MULTI-BAND LIGATOR | Wilson-Cook Medical, Inc. | 1998-01-20 | 90 | 1 |
| K963166 | O'REGAN LIGATOR | Patrick J. O'Regan | 1997-05-05 | 264 | 0 |
| K964079 | SPEEDBAND MULTIPLE BAND LIGATOR | Boston Scientific Corp | 1997-02-13 | 125 | 0 |
| K960020 | SOLO BAND LIGATOR | Surcraft, LLC | 1996-04-01 | 90 | 0 |
| K952262 | SPEEDBAND | Boston Scientific Corp | 1996-02-29 | 290 | 0 |
| K882297 | 1/2 CM REAR TIP EXTENDER (RTE) | American Medical Systems, Inc. | 1988-06-17 | 15 | 0 |
| K880648 | ENDOSCOPIC ELASTIC BAND LIGATOR | Superior Healthcare Group, Inc. | 1988-04-06 | 49 | 0 |
| K832192 | SUCTION-HEMORRHOID-LIGATOR | Research Endoscope Systems Intl. | 1983-12-27 | 172 | 0 |
| K801352 | HEMORRHOIDAL LIGATION INSTR. SYSTEM | Depuy, Inc. | 1980-07-08 | 29 | 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