Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HRW — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
18 daysmedian FDA review time
53 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971407 | JTECH COMMANDER AND ALGOMETER | J-Tech Medical, Inc. | 1998-04-20 | 369 | 0 |
| K970870 | DIGIT-GRIP WITH LCD (DGR002) | Nk Biotechnical Corp. | 1997-05-02 | 53 | 0 |
| K894557 | LIGHTSCOPE SET | Optik | 1989-08-07 | 18 | 0 |
| K861396 | HANDHELD DYNAMOMETER, MODEL #160 AND #111 | Spark Instruments & Academics, Inc. | 1986-05-02 | 17 | 0 |
| K821631 | PINCH GAUGE, 0-301 LBS. | Fred Sammons, Inc. | 1982-06-11 | 8 | 0 |
| K812343 | PINCH METER | Fred Sammons, Inc. | 1981-09-11 | 24 | 0 |
| K801719 | BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG | Fred Sammons, Inc. | 1980-08-04 | 11 | 0 |
| K791021 | MUSCLE TESTING GUN | The Orthodyn Co. | 1979-06-15 | 16 | 0 |
| K790302 | PRESSURE MONITOR, MODEL 212 | Zatek | 1979-03-21 | 36 | 0 |
| K772415 | DYNAMETER 50 LB. | Fred Sammons, Inc. | 1978-01-05 | 9 | 0 |
| K772413 | PINCH GUAGE | Fred Sammons, Inc. | 1978-01-05 | 9 | 0 |
| K771288 | JAMAR DYNAMOMETEO BK-7498 | Fred Sammons, Inc. | 1977-07-21 | 38 | 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