Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Air-Shields, Inc. — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
411 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974248 | WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM | Air-Shields, Inc. | 1998-10-07 | 329 | 0 |
| K972309 | JM-102 JAUNDICE METER | Air-Shields, Inc. | 1998-09-22 | 459 | 0 |
| K971256 | DUO-LITE PHOTOTHERAPY SYSTEM | Air-Shields, Inc. | 1997-09-24 | 173 | 0 |
| K960980 | ISOLETTE INFANT INCUBATOR | Air-Shields, Inc. | 1996-07-30 | 141 | 0 |
| K924709 | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | Air-Shields, Inc. | 1996-01-17 | 1216 | 0 |
| K940951 | RW RESUCITAIRE INFANT RADIANT WARMER | Air-Shields, Inc. | 1995-05-03 | 427 | 0 |
| K940975 | C450/C400 INFANT INCUBATORS | Air-Shields, Inc. | 1994-06-23 | 112 | 0 |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Air-Shields, Inc. | 1994-06-10 | 95 | 1 |
| K924170 | ISOLETTE INCUBATOR HUMIDITY METER | Air-Shields, Inc. | 1993-02-05 | 170 | 0 |
| K922150 | EXAMINATION LAMP | Air-Shields, Inc. | 1992-07-21 | 75 | 0 |
| K914864 | MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR | Air-Shields, Inc. | 1992-03-13 | 136 | 0 |
| K913291 | MODEL C386 ISOLETTE(R) INFANT INCUBATOR | Air-Shields, Inc. | 1991-11-13 | 112 | 0 |
| K874326 | SYSTEM VI MONITOR | Air-Shields, Inc. | 1988-12-05 | 411 | 0 |
| K880781 | DATALOGGER CHART RECORDER | Air-Shields, Inc. | 1988-05-11 | 75 | 0 |
| K875270 | INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS | Air-Shields, Inc. | 1988-01-19 | 28 | 0 |
| K872742 | WARM WEIGH MODELS I-20/W-30 INFANT SCALE | Air-Shields, Inc. | 1987-10-20 | 102 | 0 |
| K871594 | BIRTHING ROOM WARMER | Air-Shields, Inc. | 1987-06-05 | 42 | 0 |
| K870888 | WARM WEIGH MODEL N-10 INFANT SCALE | Air-Shields, Inc. | 1987-03-17 | 12 | 0 |
| K861781 | DELIVERY ROOM WARMER | Air-Shields, Inc. | 1986-07-15 | 68 | 0 |
| K861743 | AS165 RESPIRATION MONITOR | Air-Shields, Inc. | 1986-05-09 | 3 | 0 |
| K842321 | AIR SHIELDS AS461 MONITORING SYS | Air-Shields, Inc. | 1984-08-03 | 52 | 0 |
| K840454 | PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO | Air-Shields, Inc. | 1984-03-23 | 60 | 0 |
| K832754 | MONITORING SYSTEM AS100-AS115 RECORD | Air-Shields, Inc. | 1983-12-22 | 128 | 0 |
| K781876 | ISOLETTE INCUBATOR | Air-Shields, Inc. | 1978-12-07 | 35 | 0 |
| K781276 | X-RAY, PORTABLE | Air-Shields, Inc. | 1978-08-10 | 17 | 0 |
| K780876 | ULTRASONIC IMAGER | Air-Shields, Inc. | 1978-06-27 | 28 | 0 |
| K780472 | INFANT INCUBATOR | Air-Shields, Inc. | 1978-04-19 | 26 | 0 |
| K780503 | INFUSION PUMP | Air-Shields, Inc. | 1978-04-10 | 12 | 0 |
| K771541 | FETAL MONITORING SYSTEM | Air-Shields, Inc. | 1977-08-25 | 14 | 0 |
| K771350 | AMBU RESUSCITATOR | Air-Shields, Inc. | 1977-08-19 | 29 | 0 |
| K760872 | PHOTOTHERAPY LIGHT | Air-Shields, Inc. | 1976-11-02 | 15 | 0 |
| K760663 | MVP-10 PEDIATRIC/NEONATAL VENTILATOR | Air-Shields, Inc. | 1976-09-27 | 10 | 0 |
| K760104 | RESPIRATION MONITOR | Air-Shields, Inc. | 1976-09-21 | 90 | 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