510(k) · Cleared
ClearedV-2100G Advanced Infant Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atom Medical Corp · FMZ Incubator, Neonatal
Cleared on Jul 18, 2002 after a 45-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Jul 18, 2002
- Review
- 45 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK021809 V-2100G Advanced Infant IncubatorAtom Medical Corp · 2002
- Descendant · cites it directly · 4 of its ownK061856 V-2200 Infant IncubatorAtom Medical, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK102710 Neo-Servo IAtom Medical Corporation · 2010
- Descendant · 3 generations on · 0 of its ownK132543 Infant IncubatorBistos Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK102226 Dual Incu IAtom Medical Corporation · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK102279 INCU IAtom Medical Corporation · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061856V-2200 Infant IncubatorAtom Medical, Inc. · 2006 · cites it directly4descendants
- K102710Neo-Servo IAtom Medical Corporation · 2010 · 2 generations on1descendant
- K132543Infant IncubatorBistos Co., Ltd. · 2014 · 3 generations on0descendants
- K102226Dual Incu IAtom Medical Corporation · 2011 · 2 generations on0descendants
- K102279INCU IAtom Medical Corporation · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021809 | V-2100G Advanced Infant Incubator | Atom Medical Corp | 2002 | — |
| +1 | K061856 | V-2200 Infant Incubator | Atom Medical, Inc. | 2006 | — |
| +2 | K102710 | Neo-Servo I | Atom Medical Corporation | 2010 | — |
| +3 | K132543 | Infant Incubator | Bistos Co., Ltd. | 2014 | — |
| +2 | K102226 | Dual Incu I | Atom Medical Corporation | 2011 | 5 |
| +2 | K102279 | INCU I | Atom Medical Corporation | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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.
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 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 |
|---|---|---|---|
| * | — | Air Shields Isolette Infant Incubators and Accessories Named without a submission number | |
| * | — | Ohmeda Ohio Care Plus Infant Incubators and Accessories Named without a submission number |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K061856 (Atom Medical, Inc., 2006) has gone furthest, with 4 descendants of its own.
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 V-2100G Advanced Infant Incubator is a hooded container that is intended to provide a controlled thermal environment and isolation from ambient air for premature and neonatal infants. The V-2100G is not intended for the transport of infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021809: V-2100G Advanced Infant Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021809
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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