510(k) Report

510(k) · Cleared

Recalled · 2008

Model TI500 Isolette Infant Incubator

K941106510(k) TraditionalCleared Jun 10, 199495-day reviewClass II21 CFR 880.5410Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Air-Shields, Inc. · FPL Incubator, Neonatal Transport

Cleared on Jun 10, 1994 after a 95-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled once.

Decided
Jun 10, 1994
Review
95 days
Class
Class II
Product code
FPL
Recalls
1
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2013: 1 descendant cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK941106 Model TI500 Isolette Infant IncubatorAir-Shields, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK123937 Atom Transcapsule V-707Atom Medical Corporation · 2013
  3. Descendant · cites it directly · 0 of its ownK081264 Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002Children'S Health First, Inc. · 2009
  4. Descendant · cites it directly · 0 of its ownK061071 V-808 Atom TranscapsuleAtom Medical, Inc. · 2006

Most influential descendants

Showing 3 of 3 · See all
  • K123937Atom Transcapsule V-707Atom Medical Corporation · 2013 · cites it directly0descendants
  • K081264Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002Children'S Health First, Inc. · 2009 · cites it directly0descendants
  • K061071V-808 Atom TranscapsuleAtom Medical, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K941106Model TI500 Isolette Infant IncubatorAir-Shields, Inc.1994—
+1K123937Atom Transcapsule V-707Atom Medical Corporation2013—
+1K081264Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002Children'S Health First, Inc.2009—
+1K061071V-808 Atom TranscapsuleAtom Medical, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201310
FIG. 1 — Lineage of K941106, 1994–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FPL device

  1. #1 K220742 NxtGen Infant Transport Incubatorscore 4.3 · 3 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123937Atom Transcapsule V-707Atom Medical Corporation20130
K081264Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002Children'S Health First, Inc.20090
K061071V-808 Atom TranscapsuleAtom Medical, Inc.20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 31, 2008Not classifiedZ-1051-2008Nonconforming Material/ComponentHeating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K123937 (Atom Medical Corporation, 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FPL devices

FPL Incubator, Neonatal Transport: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPL

1in 2022

2008: 12011: 42013: 12014: 12017: 12022: 1
2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPL

148in 2011

2011: 148 days median
2007high 148 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPL

No recall names FPL since 2007.

Adverse event reports per year · FPL

3in 2024

2010: 42011: 12013: 32014: 12015: 12016: 12018: 22020: 12021: 22022: 12024: 3
2007high 4 (2010) · low 0 (2007)2025

MAUDE reports naming product code FPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20100—04
2011414801
20120—00
20131—03
20141—01
20150—01
20160—01
20171—00
20180—02
20190—00
20200—01
20210—02
20221—01
20230—00
20240—03
20250—00
20260—0—

More from Air-Shields, Inc.

33 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in FPL

The FPL category page

  • K220742NxtGen Infant Transport IncubatorInternational Biomedical · 2022
  • K161918SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical Systems · 2017
  • K141565Globe-Trotter GT5400Draeger Medical Systems, Inc. · 20141 recall
  • K123937Atom Transcapsule V-707Atom Medical Corporation · 2013
  • K103523185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor PulseoxInternational Biomedical, Ltd. · 2011

https://510kreport.com/device/K941106 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941106: Model TI500 Isolette Infant Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941106

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026