510(k) Report

510(k) · Cleared

Cleared

Infant Life Support Module-20

K854065510(k) TraditionalCleared Jan 16, 1986104-day reviewClass II21 CFR 880.5410

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

Intl. Biomedics, Inc. · FPL Incubator, Neonatal Transport

Cleared on Jan 16, 1986 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jan 16, 1986
Review
104 days
Class
Class II
Product code
FPL
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2011: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK854065 Infant Life Support Module-20Intl. Biomedics, Inc. · 1986
  2. Descendant · cites it directly · 2 of its ownK022876 Modification to Infant Life Support Module-20International Biomedical, Inc. · 2002
  3. Descendant · 2 generations on · 1 of its ownK103524 Voyager Transport Incubator with Masimo Pulseox, Voyager Transport…International Biomedical, Ltd. · 2011
  4. Descendant · 3 generations on · 0 of its ownK220742 NxtGen Infant Transport IncubatorInternational Biomedical · 2022

Most influential descendants

Showing 3 of 3 · See all
  • K022876Modification to Infant Life Support Module-20International Biomedical, Inc. · 2002 · cites it directly2descendants
  • K103524Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with…International Biomedical, Ltd. · 2011 · 2 generations on1descendant
  • K220742NxtGen Infant Transport IncubatorInternational Biomedical · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K854065Infant Life Support Module-20Intl. Biomedics, Inc.1986—
+1K022876Modification to Infant Life Support Module-20International Biomedical, Inc.2002—
+2K103524Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator…International Biomedical, Ltd.2011—
+3K220742NxtGen Infant Transport IncubatorInternational Biomedical2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201110
202210
FIG. 1 — Lineage of K854065, 1986–2022Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022876Modification to Infant Life Support Module-20International Biomedical, Inc.20022

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K022876 (International Biomedical, Inc., 2002) has gone furthest, with 2 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 Intl. Biomedics, Inc.

2 FDA decisions under this applicant name. See the company

  • K882551Ambulatory PH Data Recorder System, Aph-2000Intl. Biomedics, Inc. · 1988

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/K854065 · printed Nov 6, 2026

Cite this page

510(k) Report. “K854065: Infant Life Support Module-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854065

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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