Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brentwood Instruments, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
214 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896924 | SPIROSCAN 4000 | Brentwood Instruments, Inc. | 1990-03-01 | 79 | 0 |
| K882366 | RHYTHMSCAN HR HOLTER RECORDER | Brentwood Instruments, Inc. | 1988-08-02 | 55 | 0 |
| K871572 | RHYTHMSCAN | Brentwood Instruments, Inc. | 1988-02-22 | 306 | 0 |
| K860024 | FUKUDA DENSHI CARDIMAX FCP-211 | Brentwood Instruments, Inc. | 1986-03-31 | 87 | 0 |
| K853979 | CARDIMAX FX-1164 | Brentwood Instruments, Inc. | 1986-02-06 | 133 | 0 |
| K854505 | CARDIMAX FX-406U | Brentwood Instruments, Inc. | 1986-02-04 | 84 | 0 |
| K851135 | SPIRO SCAN | Brentwood Instruments, Inc. | 1985-07-01 | 102 | 0 |
| K851123 | R-1000 ECG RECEIVER | Brentwood Instruments, Inc. | 1985-05-15 | 57 | 0 |
| K851124 | T-1000 ECG TRANSMITTER | Brentwood Instruments, Inc. | 1985-05-15 | 57 | 0 |
| K842976 | BRENTWOOD EZ SCAN 200 AMBULATORY ECG | Brentwood Instruments, Inc. | 1985-03-01 | 214 | 0 |
| K844470 | FUKUDA DENSHI MODEL FCP-220 | Brentwood Instruments, Inc. | 1985-01-10 | 52 | 0 |
| K833594 | FUKUDA DENSHI FX-302 AUTO/THREE CHAN | Brentwood Instruments, Inc. | 1984-09-11 | 335 | 0 |
| K833593 | FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN | Brentwood Instruments, Inc. | 1984-05-09 | 210 | 0 |
| K842169 | FCP-11ECG | Brentwood Instruments, Inc. | 1984-03-13 | 0 | 0 |
| K830907 | AMBULATORY ECG EVENT RECORDER | Brentwood Instruments, Inc. | 1983-07-28 | 129 | 0 |
| K823586 | COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 | Brentwood Instruments, Inc. | 1983-04-06 | 121 | 0 |
| K823585 | COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 | Brentwood Instruments, Inc. | 1983-04-06 | 121 | 0 |
| K823584 | FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO- | Brentwood Instruments, Inc. | 1982-12-30 | 24 | 0 |
| K813021 | FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36 | Brentwood Instruments, Inc. | 1981-12-14 | 48 | 0 |
| K813022 | FUKUDA DENSHI CARDIMAX FK-12 | Brentwood Instruments, Inc. | 1981-12-02 | 36 | 0 |
| K813023 | FUKUDA DENSHI CARDIMAX FK-11 | Brentwood Instruments, Inc. | 1981-12-02 | 36 | 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