Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brattle Instrument Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
23 daysmedian FDA review time
73 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810588 | SYNCHRONIZER #208 | Brattle Instrument Corp. | 1981-04-10 | 37 | 0 |
| K802978 | TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 | Brattle Instrument Corp. | 1981-02-02 | 73 | 0 |
| K781681 | PHIPIOLOGICAL SYNCHRONIZER PART#205 | Brattle Instrument Corp. | 1978-10-17 | 15 | 0 |
| K770692 | MONITOR, FETAL, NO. L04-1100 | Brattle Instrument Corp. | 1977-04-26 | 12 | 0 |
| K770296 | FETAL MONITOR, PART #101-11009 | Brattle Instrument Corp. | 1977-03-09 | 23 | 0 |
| K770297 | FETAL MONITOR, PART #100-11009 | Brattle Instrument Corp. | 1977-03-09 | 23 | 0 |
| K770295 | ABDOMINAL ECG PROCESSOR FOR FETAL MONI. | Brattle Instrument Corp. | 1977-03-09 | 23 | 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