Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MLY — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
178 daysmedian FDA review time
526 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243654 | DentalJect | Vapocoolshot, Inc. | 2025-05-30 | 185 | 0 |
| K232674 | PainFreeze II | Nuance Medical, LLC | 2024-02-12 | 164 | 0 |
| K203661 | CRYO Arctic, CRYO Penguin | Cryoscience North America, Inc. | 2022-05-25 | 526 | 0 |
| K202782 | num Vapocoolant | 623 Medical, LLC | 2020-12-21 | 90 | 0 |
| K201248 | Syringe Holder accessory | Vapocoolshot, Inc. | 2020-08-12 | 93 | 0 |
| K193349 | Vapocoolshot Mist | Vapocoolshot, Inc. | 2020-04-14 | 133 | 0 |
| K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoi | Gebauer Company | 2019-05-07 | 97 | 0 |
| K172598 | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry | Itw Contamination Control Electronics | 2018-04-19 | 233 | 0 |
| K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mis | Gebauer Company | 2017-10-27 | 114 | 0 |
| K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray | Nuance Medical, LLC | 2017-10-18 | 89 | 0 |
| K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™ | Nuance Medical, LLC | 2016-11-22 | 106 | 0 |
| K093951 | OUCHLESS MODEL PN10114 | Occam Design | 2010-06-15 | 174 | 0 |
| K033720 | ARI COLD SPRAY | Ari | 2005-06-10 | 562 | 0 |
| K032671 | GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REF | Gebauer Co. | 2004-03-17 | 201 | 3 |
| K030281 | CRYOTRON 2 CRYOTHERAPY DEVICE | Cryonic Medical North America | 2003-08-20 | 205 | 0 |
| K031036 | GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010 | Gebauer Co. | 2003-07-10 | 100 | 1 |
| K021726 | GEBAUER'S INSTANT ICE | Gebauer Co. | 2002-12-12 | 202 | 2 |
| K002596 | GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 | Gebauer Co. | 2001-02-15 | 178 | 1 |
| K001624 | GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 | Gebauer Co. | 2001-01-25 | 244 | 0 |
| K992286 | DERMAFREEZE | Rhealm Pharmaceuticals, Inc. | 2000-01-21 | 198 | 0 |
| K984564 | ETHYL CHLORIDE DISPENSER | Dukal Corp. | 1999-12-02 | 344 | 0 |
| K991514 | GEBAUER'S CHLORIDE FINE NOZZE | Gebauer Co. | 1999-07-16 | 77 | 0 |
| K930915 | FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE | Gebauer Co. | 1994-09-29 | 583 | 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