510(k) · Cleared
ClearedVersalet 7700 Care Center
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Infant Care, Inc. · FMZ Incubator, Neonatal
Cleared on Aug 4, 2006 as substantially equivalent to K993051 (Hill-Rom Air-Shields, 2000) and 1 other predicate after a 241-day review. Its family tree reaches back 4 generations to 1995. 1 of the 14 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 4, 2006
- Review
- 241 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K942948 (1995). 13 ancestors in all, the oldest K912908 (1991). No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 3 generations backK970074 Stanilet Freestanding/CC Infant/2000C Infant Warmer…Hill-Rom, Inc. · 1997
- 2 generations backK971366 IncuwarmerHill-Rom, Inc. · 1998
- 1 generation backK993051 Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000
- This deviceK053399 Versalet 7700 Care CenterDraeger Medical Infant Care, Inc. · 2006
Class I recalls in this family
- K943360 Ohio Care Plus Incubator3 generations back · 1994
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −3 | K970074 | Stanilet Freestanding/CC Infant/2000C Infant Warmer (1250C/1500C/2000D) | Hill-Rom, Inc. | 1997 | — |
| −2 | K971366 | Incuwarmer | Hill-Rom, Inc. | 1998 | — |
| −1 | K993051 | Versalet 7700 Care Center, Model # 7700 | Hill-Rom Air-Shields | 2000 | — |
| 0 (this device) | K053399 | Versalet 7700 Care Center | Draeger Medical Infant Care, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 1 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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 K251663 Giraffe OmniBed Carestation (CS1); Giraffe…score 14.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993051 | Versalet 7700 Care Center, Model # 7700Summary page 1…t Warmer Classification: General Hospital 21 CFR 880.5400, and 21 CFR 880.5130 Performance Standards: None applicable Predicate Device: K993051 Versalet 7700 Care Center K993407 Giraffe OmniBed Device Description T The Versalet M 7700 Care Center is a… | 2000 |
| * | K993407 | Ohmeda Medical OmnibedSummary page 1…Hospital 21 CFR 880.5400, and 21 CFR 880.5130 Performance Standards: None applicable Predicate Device: K993051 Versalet 7700 Care Center K993407 Giraffe OmniBed Device Description T The Versalet M 7700 Care Center is a warming device that combines the heating… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K943360Ohio Care Plus IncubatorOhmeda Medical · 1994 · 3 generations back · ◆ in the 1994 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMZ
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMZ
2in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · FMZ
250in 2025
MAUDE reports naming product code FMZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 81 | 0 | 14 |
| 2008 | 1 | — | 4 | 10 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 4 | 60 | 0 | 11 |
| 2011 | 1 | — | 5 | 10 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 1 (1) | 11 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 12 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 3 | 18 |
| 2019 | 2 | — | 1 | 24 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 0 | — | 8 (8) | 19 |
| 2024 | 0 | — | 2 (2) | 118 |
| 2025 | 2 | — | 0 | 250 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant or convective heat. Accessories and options to the device permit environmental control and monitoring and may include optional features such as humidification and in-bed scale. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053399: Versalet 7700 Care Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053399
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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