510(k) Report

FDA applicant

Air-Shields, Inc.

Hatboro, PA33 decisions1976–19981 recall

FDA records 33 decisions for Air-Shields, Inc. (Hatboro, PA) from 1976 to 1998: 33 510(k) clearances. Most are in product codes FMZ (Incubator, Neonatal) and FMT (Warmer, Infant Radiant). Its devices cite 6 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Air-Shields, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Air-Shields, Inc. since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Air-Shields, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Air-Shields, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FMZIncubator, Neonatal7decisions
  • FMTWarmer, Infant Radiant5decisions
  • LBIUnit, Neonatal Phototherapy3decisions
  • DSFRecorder, Paper Chart2decisions
  • HGMSystem, Monitoring, Perinatal2decisions
  • BZQMonitor, Breathing Frequency1decision

Also: MQM (1), FPL (1), DRT (1), KLK (1), HEM (1), IZL (1).

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K940951RW Resucitaire Infant Radiant WarmerAir-Shields, Inc. · 19955cite it
  • K960980Isolette Infant IncubatorAir-Shields, Inc. · 19964cite it
  • K941106Model TI500 Isolette Infant IncubatorAir-Shields, Inc. · 19943cite it
  • K875270Infant Intensive Care System Vertical Height AdjusAir-Shields, Inc. · 19882cite it
  • K972309JM-102 Jaundice MeterAir-Shields, Inc. · 19981cites it
  • K974248Watchchild Obsterical Patient Data Management SystemAir-Shields, Inc. · 19981cites it

What has FDA decided for it lately?

  • K974248Watchchild Obsterical Patient Data Management SystemAir-Shields, Inc. · 1998
  • K972309JM-102 Jaundice MeterAir-Shields, Inc. · 1998
  • K971256Duo-Lite Phototherapy SystemAir-Shields, Inc. · 1997
  • K960980Isolette Infant IncubatorAir-Shields, Inc. · 1996
  • K924709Satcare Oxygen Controller/Monitor W/ Pulse OximeteAir-Shields, Inc. · 1996
  • K940951RW Resucitaire Infant Radiant WarmerAir-Shields, Inc. · 1995
  • K940975C450/C400 Infant IncubatorsAir-Shields, Inc. · 1994
  • K941106Model TI500 Isolette Infant IncubatorAir-Shields, Inc. · 19941 recall

All 33 as Air-Shields, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K941106Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical…Jan 31, 2008