510(k) Report

510(k) · Cleared

Cleared

Medix PC-305 Neonatal Incubator

K920049510(k) TraditionalCleared May 21, 1993501-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

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

Cleared on May 21, 1993 after a 501-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
May 21, 1993
Review
501 days
Class
Class II
Product code
FMZ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared1990200020102020
  1. This deviceK920049 Medix PC-305 Neonatal IncubatorMedix I.C.S.A. · 1993
  2. Descendant · cites it directly · 0 of its ownK070291 Medix Natal Care Intensive Care Incubator, Models-Natal Care…Medix I.C.S.A. · 2007 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K070291Medix Natal Care Intensive Care Incubator, Models-Natal Care ST-MX/LX/BXMedix I.C.S.A. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920049Medix PC-305 Neonatal IncubatorMedix I.C.S.A.1993—
+1K070291Medix Natal Care Intensive Care Incubator, Models-Natal Care ST-MX/LX/BXMedix I.C.S.A.20072

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K920049, 1993–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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?

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

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K070291Medix Natal Care Intensive Care Incubator, Models-Natal Care ST-MX/LX/BXMedix I.C.S.A.20070

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, K070291 (Medix I.C.S.A., 2007) has gone furthest, with 0 descendants of its own.

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—

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
  • K070291Medix Natal Care Intensive Care Incubator, Models-Natal Care ST-MX/LX/BXMedix I.C.S.A. · 20072 recalls
  • K931529Infant WarmerMedix I.C.S.A. · 1994
  • K931965Medix Phototherapy LampMedix 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/K920049 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920049: Medix PC-305 Neonatal Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920049

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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