510(k) Report

510(k) · Cleared

Cleared

V-2200 Infant Incubator

K061280510(k) TraditionalCleared Jun 27, 200650-day reviewClass II21 CFR 880.5400

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

Neoforce Group, Inc. · FMZ Incubator, Neonatal

Cleared on Jun 27, 2006 as substantially equivalent to K001242 (Hill-Rom Air-Shields, 2000) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 2000.

Decided
Jun 27, 2006
Review
50 days
Class
Class II
Product code
FMZ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K001242 (2000). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestorK001242 · Isolette Infant Incubator, Model C2HS · Hill-Rom Air-Shields · 200020002002200420062008
Other ancestors, by generation 1 generation back: 1 other ancestor K001242 · Isolette Infant Incubator, Model C2HS · Hill-Rom Air-Shields · 20000
  1. Root · 1 generation backK001242 Isolette Infant Incubator, Model C2HSHill-Rom Air-Shields · 2000
  2. This deviceK061280 V-2200 Infant IncubatorNeoforce Group, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001242Isolette Infant Incubator, Model C2HSHill-Rom Air-Shields2000—
0 (this device)K061280V-2200 Infant IncubatorNeoforce Group, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K061280, 2000–2006Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMZ? 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 FMZ device

  1. #1 K251663 Giraffe OmniBed Carestation (CS1); Giraffe…score 14.4 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K001242Isolette Infant Incubator, Model C2HS
Summary page 1
…fication: General Hospital 21 CFR 880.5400 Infant Incubator, FMZ, Class II Performance Standards: None applicable Predicate Device: K001242 C2000 Isolette Infant Incubator K021809 V2100OG Infant Incubator Device Desciiption 510(k) Supplement…
Hill-Rom Air-Shields2000—
*K021809V-2100G Advanced Infant Incubator
Summary page 1
…R 880.5400 Infant Incubator, FMZ, Class II Performance Standards: None applicable Predicate Device: K001242 C2000 Isolette Infant Incubator K021809 V2100OG Infant Incubator Device Desciiption 510(k) Supplement NeoForce Group, Inc…
Atom Medical Corp2002—

Also cleared against K001242: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.
  • 6 other devices also cite its predicate K001242.

How does its category compare?

All FMZ devices

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

FDA decisions per year · FMZ

2in 2025

2007: 32008: 12010: 42011: 12014: 12015: 12016: 12017: 12018: 22019: 22022: 12025: 22026 (partial year): 2
2007high 4 (2010) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMZ

60in 2010

2007: 81 days median2010: 60 days median
2007high 81 (2007) · low 60 (2010)2026

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

Recalls per year · FMZ

2in 2024

2008: 42011: 52013: 1, 1 Class I2016: 12018: 32019: 12023: 8, 8 Class I2024: 2, 2 Class I2026 (partial year): 3
2007high 8 (2023) · low 0 (2007)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · FMZ

250in 2025

2007: 142008: 102009: 82010: 112011: 102012: 122013: 112014: 32015: 92016: 122017: 42018: 182019: 242020: 82021: 152022: 272023: 192024: 1182025: 250
2007high 250 (2025) · low 3 (2014)2025

MAUDE reports naming product code FMZ, 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
2007381014
20081—410
20090—08
2010460011
20111—510
20120—012
20130—1 (1)11
20141—03
20151—09
20161—112
20171—04
20182—318
20192—124
20200—08
20210—015
20221—027
20230—8 (8)19
20240—2 (2)118
20252—0250
20262—3—

What is it indicated for?

The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

This device is not intended for home use.

This device is not intended as a transport incubator.

Indications for use as stated in the FDA summary.

Also cleared against K001242

6 other devices cite the same predicate.

  • K172154Isolette 8000 plusDraeger Medical Sytems, Inc. · 2018
  • K071977Tarry Medical Temperature ProbesTarry Medical Products, Inc. · 2008
  • K070291Medix Natal Care Intensive Care Incubator, Models-Natal Care ST-MX/LX/BXMedix I.C.S.A. · 20072 recalls
  • K020547Ohmeda Medical Giraffe IncubatorOhmeda Medical · 20024 recalls
  • K020543Ohmeda Medical Giraffe OmnibedOhmeda Medical · 20022 Class I recalls
  • K020219Rpi Skin or Air Temperature ProbeReplacement Parts Industries, Inc. · 2002

More from Neoforce Group, Inc.

7 FDA decisions under this applicant name. See the company

  • K110119Pressure ManometerNeoforce Group, Inc. · 2011
  • K103833Neopip Patient Circuit with PeepNeoforce Group, Inc. · 2011
  • K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
  • K092085Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
  • K072021Neopip Infant ResuscitatorNeoforce Group, Inc. · 2007

Recent decisions in FMZ

The FMZ category page

  • K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2026
  • K251619Babyleo TN500Drägerwerk AG & Co. KGaA · 2026
  • K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025
  • K243437mOm Essential Incubator (ME1)Mom Incubators Limited · 2025
  • K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 20221 Class I recall

https://510kreport.com/device/K061280 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061280: V-2200 Infant Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061280

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026