Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A Company, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
68 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K897195 | A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) | A Company, Inc. | 1990-05-31 | 153 | 0 |
| K852670 | A-COMPANY ESPREE SAFETY HEADGEAR | A Company, Inc. | 1985-07-31 | 37 | 0 |
| K852598 | A-COMPANY SEPARATING ELASTICS | A Company, Inc. | 1985-07-31 | 42 | 0 |
| K852596 | A-COMPANY ELASTIC LIGATURE RINGS | A Company, Inc. | 1985-07-31 | 42 | 0 |
| K852800 | A-COMPANY SELF-LIGATING APPLIANCE | A Company, Inc. | 1985-07-31 | 30 | 0 |
| K852599 | A-COMPANY ELASTOMERIC TUBING | A Company, Inc. | 1985-07-31 | 42 | 0 |
| K852597 | A-COMPANY ELASTIC ROTATION WEDGES | A Company, Inc. | 1985-07-31 | 42 | 0 |
| K852600 | A-COMPANY ELASTOMERIC CHAIN DISPENSER | A Company, Inc. | 1985-07-31 | 42 | 0 |
| K851878 | A COMPANY BRASS SEPARATING RINGS | A Company, Inc. | 1985-06-05 | 37 | 0 |
| K851454 | A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS | A Company, Inc. | 1985-04-29 | 18 | 0 |
| K844067 | VANISH ORTHODONTIC BRACKET | A Company, Inc. | 1984-11-23 | 36 | 0 |
| K843705 | MANDIBULATOR JAW POSITIONER | A Company, Inc. | 1984-11-14 | 54 | 0 |
| K841638 | ALINE ORTHODONTIC ARCHWIRE | A Company, Inc. | 1984-06-27 | 68 | 0 |
| K820568 | MUSCLE DYSFUNCTION MONITOR | A Company, Inc. | 1982-04-09 | 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