Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KPJ — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
162 daysmedian FDA review time
428 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250188 | Wound Treatment System (VHT-200) | Vaporox, Inc. | 2025-03-10 | 47 | 0 |
| K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | 2023-03-23 | 624 | 0 |
| K190742 | EPIFLO-28 | Neogenix, LLC Dba Ogenix | 2019-12-13 | 266 | 0 |
| K112634 | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | Inotec Amd , Ltd. | 2012-07-03 | 298 | 0 |
| K120764 | EPIFLO(R) | Neogenix, LLC | 2012-04-27 | 45 | 0 |
| K090681 | TANSCU O2 | Electrochemical Oxygen Concepts, Inc. | 2009-08-12 | 149 | 0 |
| K080966 | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | Aoti , Ltd. | 2008-08-06 | 124 | 0 |
| K050156 | WHS-1000 WOUND HEALING SYSTEM | Iyia Technologies, Inc. | 2005-06-17 | 144 | 0 |
| K023456 | OXYBOX SYSTEM | Oxyfast Corporation | 2003-02-24 | 132 | 2 |
| K022028 | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER | Vascular One, Inc. | 2002-12-17 | 179 | 0 |
| K020466 | HEC 1000 | Metro Medical Equipment, Inc. | 2002-05-08 | 85 | 0 |
| K002632 | OXYGENATOR | Adjunctive Therapeutics, Inc. | 2001-10-25 | 428 | 0 |
| K981949 | NUMOBAG | Numotech, Inc. | 1999-02-03 | 245 | 0 |
| K971507 | O2 BOOT | Gwr Medical, Llp | 1997-11-07 | 196 | 0 |
| K960756 | LIFETECH CASSETTE | Lifetech Systems, Inc. | 1997-08-29 | 553 | 0 |
| K963777 | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-10 | Stephenson Industries, Inc. | 1997-07-28 | 311 | 0 |
| K920948 | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER | Topox Therapeuutic Rentals, Inc. | 1992-08-11 | 162 | 0 |
| K883848 | KMI OXY-BAN | Knight Medical, Inc. | 1989-03-02 | 171 | 0 |
| K882461 | O2 CARE | Ballard Medical Products | 1988-11-28 | 166 | 0 |
| K861593 | TOPICAL HYPERBARIC OXYGEN CHAMBER | Stephenson Industries, Inc. | 1986-05-12 | 13 | 0 |
| K861101 | THE NEW FLEXIBLE COLLAPSIBLE CHAMBER | Stephenson Industries, Inc. | 1986-05-06 | 43 | 0 |
| K840817 | DISPOSABLE, HYPERBARIC OXYGEN CHAMBER | Hospitak, Inc. | 1984-04-25 | 61 | 0 |
| K831825 | DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM | Hospitak, Inc. | 1983-10-27 | 142 | 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