Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JXL — Predicate Candidate Screening
28 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
278 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221469 | PATI (Protector Against Tongue Injury) | Neurovice, LLC | 2023-02-22 | 278 | 0 |
| K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -si | Mecta Corporation | 2021-06-04 | 385 | 0 |
| K172978 | SurgeoBite | Surgovations, LLC | 2017-12-22 | 86 | 0 |
| K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway wi | Dupaco, Inc. | 2015-06-29 | 119 | 0 |
| K050188 | EPIGUARD | Episafe Medical Devices, Ltd. | 2005-04-27 | 90 | 0 |
| K992269 | VENTIL-A ORAL PROTECTOR | Somatics, Inc. | 1999-10-25 | 111 | 0 |
| K960663 | UNIVERSAL BITE BLOCK | B&B Medical Technologies, Inc. | 1996-05-17 | 91 | 0 |
| K954352 | BITE BLOCK | United States Endoscopy Group, Inc. | 1996-01-25 | 129 | 0 |
| K941856 | PREMIER PROMAX BITE GUARD | Premier Dental Products Co. | 1995-04-05 | 355 | 0 |
| K924333 | THE DAVIS DISPOSABLE PROTECTIVE SPLINT | Ora-Gard, Inc. | 1993-04-23 | 239 | 0 |
| K924304 | BITE BLOCK | United States Endoscopy Group, Inc. | 1993-04-06 | 223 | 0 |
| K921946 | TUM-E-VAC BITE BLOCK | Ethox Corp. | 1992-12-09 | 226 | 0 |
| K901563 | MOUTHPIECE BREATHING | Scott All-Sports, Inc. | 1990-06-28 | 86 | 0 |
| K896745 | JAW BLOCKER | Plastic Engineered Products Co. | 1989-12-14 | 14 | 0 |
| K890567 | BITE BLOCK #59430 | Medi-Source, Inc. | 1989-02-17 | 11 | 0 |
| K883416 | MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) | Scott All-Sports, Inc. | 1988-10-12 | 58 | 0 |
| K864962 | OBERTO MOUTH PROP | Medovations, Inc. | 1987-02-19 | 59 | 0 |
| K864181 | SOMATICS MOUTH GUARD (BITE BLOCK) | Somatics, Inc. | 1986-11-03 | 7 | 0 |
| K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | Hi Chem, Inc. | 1986-06-05 | 20 | 0 |
| K842788 | DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE | Brimms, Inc. | 1984-09-11 | 50 | 0 |
| K840789 | BITESTICK BLOCK | Cherry Plastics, Inc. | 1984-04-05 | 62 | 0 |
| K830090 | DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR | Hudson Oxygen Therapy Sales Co. | 1983-02-07 | 27 | 0 |
| K822018 | JACKSON BITE BLOCKS | Kelleher Corp. | 1982-08-03 | 26 | 0 |
| K802696 | DENTAL MOUTH PROP. | Trident Dental, Inc. | 1980-11-12 | 13 | 0 |
| K800369 | TRI PAC MOUTH PROP | Oxequip Health Ind. | 1980-02-28 | 8 | 0 |
| K792157 | DENTAL MOUTHPROP (BITE BLOCK) | Mission Dental, Inc. | 1979-11-13 | 15 | 0 |
| K770090 | BLACHLY BITE BLOK & CHEEK FILLER | P.H. Blachly, M.D. | 1977-01-31 | 14 | 0 |
| K760258 | BITE STICK, DYNA | Dyna-Med | 1976-07-26 | 6 | 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