Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aequitron Medical, Inc. · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
333 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961972 | MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR | Aequitron Medical, Inc. | 1997-04-18 | 333 | 0 |
| K952880 | MODEL LP-1000 VOLUME VENTILATOR | Aequitron Medical, Inc. | 1996-06-20 | 364 | 0 |
| K944654 | OXYGEN CONCENTRATION INDICATOR | Aequitron Medical, Inc. | 1994-11-08 | 48 | 0 |
| K914424 | MODEL 6213 REMOTE ALARM | Aequitron Medical, Inc. | 1992-09-10 | 343 | 0 |
| K915381 | PORTABLE OXYGEN GENERATOR | Aequitron Medical, Inc. | 1992-03-11 | 103 | 0 |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | Aequitron Medical, Inc. | 1991-09-19 | 174 | 0 |
| K903020 | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 | Aequitron Medical, Inc. | 1991-04-10 | 273 | 0 |
| K903010 | CONTINUOUS VOLUME VENTILATOR MODEL LP10 | Aequitron Medical, Inc. | 1990-11-30 | 142 | 0 |
| K905244 | MODEL LP6 VENTILATOR, MODIFICATION | Aequitron Medical, Inc. | 1990-11-30 | 10 | 0 |
| K901656 | MODEL 9200 RESPIRATION/HEART RATE MONITOR | Aequitron Medical, Inc. | 1990-07-13 | 94 | 0 |
| K902785 | MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON | Aequitron Medical, Inc. | 1990-07-13 | 17 | 0 |
| K901251 | MODEL 9101 RECORDER/ANALYZER SYSTEM | Aequitron Medical, Inc. | 1990-05-22 | 67 | 0 |
| K882080 | MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. | Aequitron Medical, Inc. | 1989-03-01 | 288 | 0 |
| K884637 | MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR | Aequitron Medical, Inc. | 1989-01-30 | 84 | 0 |
| K881266 | MODEL 9216 RESPIRATION/HEART RATE MONITOR | Aequitron Medical, Inc. | 1988-06-10 | 78 | 0 |
| K872954 | MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR | Aequitron Medical, Inc. | 1987-10-09 | 72 | 0 |
| K871551 | MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR | Aequitron Medical, Inc. | 1987-06-05 | 44 | 0 |
| K853856 | EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET | Aequitron Medical, Inc. | 1986-03-12 | 177 | 0 |
| K853084 | MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) | Aequitron Medical, Inc. | 1985-08-02 | 10 | 0 |
| K850181 | AEQUITRON MED-7100 PHOTOTHERAPY LIGHT | Aequitron Medical, Inc. | 1985-04-05 | 77 | 0 |
| K840358 | IMPEDANCE/8200 MONITOR-MODEL 8300 | Aequitron Medical, Inc. | 1984-10-30 | 278 | 0 |
| K841363 | HEART RATE/RESPIRATION SIMULATOR 8310 | Aequitron Medical, Inc. | 1984-10-02 | 183 | 0 |
| K833348 | RESPIRATION/8100-HEART RATE RECORDER | Aequitron Medical, Inc. | 1984-04-17 | 203 | 0 |
| K833349 | EVENT TAPE RECORDER 8293 | Aequitron Medical, Inc. | 1984-04-17 | 203 | 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