Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Labac Systems, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
261 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941157 | BASIC RECLINE CHAIR | Labac Systems, Inc. | 1994-04-07 | 27 | 0 |
| K934418 | BASIC TILT CHAIR ( BTC ) | Labac Systems, Inc. | 1994-01-07 | 116 | 0 |
| K932639 | MANUAL TILT RECLINE CHAIR (MTC) | Labac Systems, Inc. | 1993-07-22 | 50 | 0 |
| K923362 | REDUCED SHEAR OWR RECLINE SYSTEM | Labac Systems, Inc. | 1993-03-26 | 261 | 0 |
| K923363 | ADJUSTABLE SLIDING BACK POWER RECLINE SYSTEM | Labac Systems, Inc. | 1993-03-24 | 259 | 0 |
| K921028 | MANUAL RECLINING CHAIR | Labac Systems, Inc. | 1993-03-24 | 386 | 0 |
| K923364 | TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST | Labac Systems, Inc. | 1993-03-22 | 257 | 0 |
| K923366 | TILT SEATING SYSTEM | Labac Systems, Inc. | 1993-02-12 | 219 | 0 |
| K925272 | PEDIATRIC TILT CHAIR | Labac Systems, Inc. | 1993-02-12 | 116 | 0 |
| K921136 | MANUAL TILT CHAIR | Labac Systems, Inc. | 1992-04-02 | 23 | 0 |
| K921027 | MANUAL CHAIR BASE | Labac Systems, Inc. | 1992-03-20 | 17 | 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