Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LGH · Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
22 daysmedian FDA review time
240 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932653 | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | Carapace, Inc. | 1994-01-28 | 240 | 0 |
| K901677 | CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER | Buckman Co., Inc. | 1990-04-23 | 13 | 0 |
| K893380 | QCR SYSTEM I AND QCR SYSTEM II | Bremer Mfg. & Tool Co., Inc. | 1989-11-16 | 199 | 0 |
| K895861 | DELTA-TECH(TM) CAST REMOVAL SYSTEM | Johnson & Johnson Professionals, Inc. | 1989-10-19 | 16 | 0 |
| K873723 | PLASTER VACUUM, 230V MODEL NO. 4183-161 | Martin Medical | 1987-12-10 | 86 | 0 |
| K873721 | PLASTER VACUUM, 115V MODEL NO. 4183-160 | Martin Medical | 1987-12-07 | 83 | 0 |
| K873719 | CAST CUTTER, 115V MODEL NO. 4183-106 | Martin Medical | 1987-10-02 | 17 | 0 |
| K873720 | CAST CUTTER, 230V MODEL NO. 4183-107 | Martin Medical | 1987-10-02 | 17 | 0 |
| K820351 | CAST CUTTER/CAST SAW/INSTRUMENT | Black & Decker(Tm) | 1982-03-02 | 22 | 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