510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Medix Natal Care Intensive Care Incubator, Models-Natal Care ST-MX/LX/BX

K070291510(k) TraditionalCleared Sep 21, 2007234-day reviewClass II21 CFR 880.5400Recalls 2

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

Medix I.C.S.A. · FMZ Incubator, Neonatal

Cleared on Sep 21, 2007 as substantially equivalent to K920049 (Medix I.C.S.A., 1993) and 1 other predicate after a 234-day review. Its family tree reaches back 1 generation to 1993. It has been recalled 2 times.

Decided
Sep 21, 2007
Review
234 days
Class
Class II
Product code
FMZ
Recalls
2
Predicates
2

Its longest line of descent runs back 1 generation to K920049 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK920049 · Medix PC-305 Neonatal Incubator · Medix I.C.S.A. · 19931990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K920049 · Medix PC-305 Neonatal Incubator · Medix I.C.S.A. · 19930
  1. Root · 1 generation backK920049 Medix PC-305 Neonatal IncubatorMedix I.C.S.A. · 1993
  2. This deviceK070291 Medix Natal Care Intensive Care Incubator, Models-Natal Care…Medix I.C.S.A. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K920049Medix PC-305 Neonatal IncubatorMedix I.C.S.A.1993—
0 (this device)K070291Medix Natal Care Intensive Care Incubator, Models-Natal Care ST-MX/LX/BXMedix I.C.S.A.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K070291, 1993–2007Source: 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
*K920049Medix PC-305 Neonatal Incubator
Summary page 1
…redicate Devices: The NATAL CARE ST-MXILXIBX incubator issubstantially equivalent to other neonatal incubators on the market such as: Medix PC-305, K920049, Medix i.c.s.a. and Isolette Infant Incubator, Model C2HS, Hill-Rom Air Shields, K001242. 3. Intended Use State…
Medix I.C.S.A.1993—
*K001242Isolette Infant Incubator, Model C2HS
Summary page 1
…r neonatal incubators on the market such as: Medix PC-305, K920049, Medix i.c.s.a. and Isolette Infant Incubator, Model C2HS, Hill-Rom Air Shields, K001242. 3. Intended Use Statement: Indications for Use: The Medix Natal Care ST-MXILXJBX Intensive Care…
Hill-Rom Air-Shields2000—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 25, 2016Class IIZ-0056-2017Unknown/Undetermined by firmNatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. There were several complaints of wheels bending out of alignment.
Jan 8, 2016Class IIZ-1363-2016Process controlNatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.

How does its category compare?

All FMZ devices

FMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 Medix Natal Care ST-MX/LX/BX Intensive Care Incubator provides

a controlled thermal environment for neonates who are unable to provide their own

thermoregulation. The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator can be

used in two operating modes: Air Control Mode and Skin Control Mode with two probes that

can be used with twins or for a follow up of central/peripheral temperature variations in a

patient as a tool for the early detection of thermal stress-effect on the newborn.

Indications for use as stated in the FDA summary.

More from Medix I.C.S.A.

6 FDA decisions under this applicant name. See the company

  • K103735Mediled MiniMedix I.C.S.A. · 2011
  • K083179Mediled Phototherapy LampMedix I.C.S.A. · 2009
  • K931529Infant WarmerMedix I.C.S.A. · 1994
  • K931965Medix Phototherapy LampMedix I.C.S.A. · 1993
  • K920049Medix PC-305 Neonatal IncubatorMedix I.C.S.A. · 1993

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/K070291 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070291: Medix Natal Care Intensive Care Incubator, Models-Natal Care ST-MX/LX/BX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070291

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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