Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alm Surgical Equipment, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
255 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982063 | ALM PRISMALIX (PRX) SURGICAL LIGHT | Alm Surgical Equipment, Inc. | 1998-09-22 | 102 | 1 |
| K961886 | DRAGER GEMINA WALL-MOUNTED WORKPLACE | Alm Surgical Equipment, Inc. | 1996-07-30 | 76 | 0 |
| K961742 | DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTE | Alm Surgical Equipment, Inc. | 1996-07-26 | 81 | 0 |
| K945102 | MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE | Alm Surgical Equipment, Inc. | 1994-11-04 | 17 | 0 |
| K942043 | DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E | Alm Surgical Equipment, Inc. | 1994-07-13 | 76 | 0 |
| K922409 | ALM ILLUMINATOR SERIES LIGHT SYSTEM | Alm Surgical Equipment, Inc. | 1993-01-12 | 236 | 0 |
| K921297 | DRAGER DVE 4000 SERIES SYSTEM | Alm Surgical Equipment, Inc. | 1992-11-27 | 255 | 0 |
| K921848 | BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT | Alm Surgical Equipment, Inc. | 1992-10-01 | 167 | 0 |
| K884019 | ALM OPERATING TABLES | Alm Surgical Equipment, Inc. | 1988-10-13 | 21 | 0 |
| K882613 | ALM SURGICAL LAMPS | Alm Surgical Equipment, Inc. | 1988-07-18 | 24 | 2 |
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