Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KDH · Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
93 daysmedian FDA review time
214 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983624 | GILTECH PLUS CONNECTING TUBE SET | Giltech Plus, Inc. | 1999-03-18 | 154 | 0 |
| K981286 | SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS | Armm, Inc. | 1998-06-19 | 72 | 0 |
| K971259 | COMBIPORT FLUID LAVAGE DEVICE | B.Braun Medical, Inc. | 1997-10-27 | 206 | 0 |
| K962850 | TUM-E-VAC | Ethox Corp. | 1997-02-21 | 214 | 0 |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Ballard Medical Products | 1995-07-05 | 93 | 0 |
| K923497 | FLUSHING IRRIGATION SET | Orion Life Systems, Inc. | 1994-03-21 | 614 | 0 |
| K920619 | TRI-MED GASTRIC LAVAGE SYSTEM | Tri-Med Specialties, Inc. | 1992-09-04 | 206 | 0 |
| K920527 | TRI-MED QUICK-STEP GASTRIC LAVAGE KIT | Tri-Med Specialties, Inc. | 1992-09-04 | 213 | 0 |
| K914908 | QUICVAGE PLUS | Autovage | 1992-04-13 | 164 | 0 |
| K914907 | QUICVAGE | Autovage | 1992-01-24 | 84 | 0 |
| K911788 | ECONOVAGE R | Autovage | 1991-07-26 | 95 | 0 |
| K911919 | MINIVAGE(R) | Autovage | 1991-07-26 | 87 | 0 |
| K911324 | IRRIGATION/ASPIRATION TUBING SET | Biomedical Dynamics, Inc. | 1991-06-24 | 90 | 0 |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | Gainor Medical Europe, Ltd. | 1990-11-20 | 173 | 0 |
| K900086 | HEMORRHOIDAL LIGATOR WITH SUCTION | Baxter Healthcare Corp | 1990-03-19 | 74 | 0 |
| K896573 | EASI-LAV ADULT GASTRIC LAVAGE KIT | Clairson Industries, LLC | 1990-01-29 | 70 | 0 |
| K892334 | LEONARD TUBE | Surgidyne, Inc. | 1989-05-31 | 56 | 0 |
| K860599 | ETHOX LAVAGE TUBE | Ethox Corp. | 1986-03-11 | 20 | 0 |
| K821496 | DISPOSABLE IRRIGA/ASPIR. SYSTEM | Innovative Surgical Products, Inc. | 1982-06-22 | 34 | 0 |
| K781749 | TUBING, AXIOM SILICONE PENROSE | Axiom Medical, Inc. | 1978-12-04 | 48 | 0 |
| K770534 | THERAPEUTIC APPARATUS, DIERKER TYPE | Well Being Ent. | 1978-04-21 | 396 | 0 |
| K770248 | ARGYLE RAPID GASTRIC LAVAGE KIT | Sherwood Medical Industries | 1977-03-09 | 30 | 0 |
| K760556 | IRRIGATION CATHETER | Sherwood Medical Industries | 1977-02-17 | 169 | 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