Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Black & Decker(Tm) — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
68 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K820351 | CAST CUTTER/CAST SAW/INSTRUMENT | Black & Decker(Tm) | 1982-03-02 | 22 | 0 |
| K812440 | POWER PACK | Black & Decker(Tm) | 1981-11-02 | 68 | 0 |
| K812439 | DUAL MPC CHARGER | Black & Decker(Tm) | 1981-11-02 | 68 | 0 |
| K812436 | 450/800 DRILL | Black & Decker(Tm) | 1981-11-02 | 68 | 0 |
| K812438 | SAGITTAL SAW | Black & Decker(Tm) | 1981-11-02 | 68 | 0 |
| K812437 | 150 DRIVER REAMER | Black & Decker(Tm) | 1981-11-02 | 68 | 0 |
| K800314 | POWER PACK | Black & Decker(Tm) | 1980-03-19 | 36 | 0 |
| K800315 | DUAL MPC CHARGER | Black & Decker(Tm) | 1980-03-19 | 36 | 0 |
| K800311 | 450 DRILL/800 DRILL | Black & Decker(Tm) | 1980-02-22 | 10 | 0 |
| K800312 | 150 DRIVER/REAMER | Black & Decker(Tm) | 1980-02-22 | 10 | 0 |
| K800313 | SAGITTAL SAW | Black & Decker(Tm) | 1980-02-22 | 10 | 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