Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sensor Medics Corp. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
187 daysmedian FDA review time
347 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032516 | HIOX80 AEROSOL ADAPTER | Sensor Medics Corp. | 2004-03-04 | 203 | 0 |
| K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION | Sensor Medics Corp. | 2004-02-13 | 253 | 0 |
| K031883 | LYRA NASAL MASK | Sensor Medics Corp. | 2003-08-25 | 68 | 0 |
| K030943 | MODIFICATION TO HIOX | Sensor Medics Corp. | 2003-04-22 | 27 | 0 |
| K022192 | PEGASUS NASAL CPAP SYSTEM | Sensor Medics Corp. | 2003-01-24 | 203 | 0 |
| K020665 | HI-OX | Sensor Medics Corp. | 2002-07-30 | 151 | 0 |
| K012085 | SOMNO STAR & SERIES SLEEP SYSTEM | Sensor Medics Corp. | 2001-08-02 | 30 | 0 |
| K012034 | MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT | Sensor Medics Corp. | 2001-07-24 | 25 | 0 |
| K991972 | INFANT FLOW SYSTEM | Sensor Medics Corp. | 1999-08-13 | 63 | 0 |
| K984254 | INFANT FLOW NCPAP MASKS | Sensor Medics Corp. | 1999-02-24 | 89 | 0 |
| K981366 | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTIO | Sensor Medics Corp. | 1998-10-30 | 198 | 0 |
| K974303 | INFANT FLOW SYSTEM | Sensor Medics Corp. | 1998-01-30 | 74 | 0 |
| K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS | Sensor Medics Corp. | 1994-11-22 | 201 | 0 |
| K934272 | SENSORMEDICS MICROGARD MICROBIAL FILTER | Sensor Medics Corp. | 1993-11-24 | 85 | 0 |
| K923988 | SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS | Sensor Medics Corp. | 1993-10-21 | 437 | 0 |
| K923989 | SENSORMEDICS MODEL 6200 AUTOBOX DL | Sensor Medics Corp. | 1993-08-09 | 363 | 0 |
| K925542 | OXYSHUTTLE II ,MODIFICATION | Sensor Medics Corp. | 1993-02-17 | 121 | 1 |
| K915833 | SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART | Sensor Medics Corp. | 1992-12-02 | 344 | 0 |
| K915686 | MODEL 2900 METABOLIC MEASUREMENT CART | Sensor Medics Corp. | 1992-12-01 | 347 | 0 |
| K915848 | SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. | Sensor Medics Corp. | 1992-10-28 | 307 | 0 |
| K915856 | SENSORMEDICS 4000 SERIES SLEEP SYSTEM | Sensor Medics Corp. | 1992-10-26 | 304 | 0 |
| K920111 | SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM | Sensor Medics Corp. | 1992-10-26 | 290 | 0 |
| K920246 | SENSORMEDICS MODEL 922 SPIROMETER | Sensor Medics Corp. | 1992-04-08 | 78 | 0 |
| K913790 | SENSORMEDICS OXYSHUTTLE II(TM) | Sensor Medics Corp. | 1992-02-26 | 187 | 0 |
| K862617 | SENSORMEDICS OXYSHUTTLE(TM) | Sensor Medics Corp. | 1986-09-26 | 79 | 0 |
| K842041 | PULMONARY FUNCTION SYSTEM | Sensor Medics Corp. | 1984-06-15 | 25 | 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