Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EGM · Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
130 daysmedian FDA review time
369 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243427 | QuickSleeper 5 | Dentalhitec | 2025-08-01 | 269 | 0 |
| K083811 | W&H HANDPIECE ANESTO, MODEL: RA-5 | W&H Dentalwerk Buermoos GmbH | 2010-01-14 | 388 | 0 |
| K964802 | CYBERJET LOCAL ANESTHESIA SYSTEM | Intra Vantage, Inc. | 1997-05-27 | 179 | 0 |
| K962017 | HYPODERMIC JET INJECTION APPARATUS | American Jet Injector Corp. | 1996-07-26 | 64 | 0 |
| K904279 | PAROJECT ANESTHETIC SYRINGE | Ronvig Instruments, Ltd. | 1990-12-07 | 81 | 0 |
| K864294 | HENKE-JECT PRESSURE SYRINGE (MODIFICATION) | Smith & Nephew, Inc. | 1987-11-04 | 369 | 0 |
| K864732 | GRADTECH SYRINGE SYSTEM | Gradtech | 1987-04-15 | 132 | 0 |
| K864861 | INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM | Instrumentations Unltd. | 1987-02-13 | 64 | 0 |
| K834361 | JSB JET SYRINGE | C.B.S. Biotechnics, Inc. | 1984-03-05 | 130 | 0 |
| K821273 | MAYO SCISSOR STRAIGHT 6 3/4 | Conphar, Inc. | 1982-05-28 | 25 | 0 |
| K790193 | MIZZY SYRIJET MARK IV | Mizzy, Inc. | 1979-04-23 | 87 | 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