510(k) · Cleared
ClearedV-2200 Infant Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atom Medical, Inc. · FMZ Incubator, Neonatal
Cleared on Sep 28, 2006 as substantially equivalent to K021809 (Atom Medical Corp, 2002) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Sep 28, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K962603 (1997). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 2 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 1 generation backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- This deviceK061856 V-2200 Infant IncubatorAtom Medical, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK102710 Neo-Servo IAtom Medical Corporation · 2010
- Descendant · 2 generations on · 0 of its ownK132543 Infant IncubatorBistos Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK102226 Dual Incu IAtom Medical Corporation · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK102279 INCU IAtom Medical Corporation · 2010
Most influential descendants
Showing 4 of 4 · See all- K102710Neo-Servo IAtom Medical Corporation · 2010 · cites it directly1descendant
- K132543Infant IncubatorBistos Co., Ltd. · 2014 · 2 generations on0descendants
- K102226Dual Incu IAtom Medical Corporation · 2011 · cites it directly0descendants
- K102279INCU IAtom Medical Corporation · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −2 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −1 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| 0 (this device) | K061856 | V-2200 Infant Incubator | Atom Medical, Inc. | 2006 | — |
| +1 | K102710 | Neo-Servo I | Atom Medical Corporation | 2010 | — |
| +2 | K132543 | Infant Incubator | Bistos Co., Ltd. | 2014 | — |
| +1 | K102226 | Dual Incu I | Atom Medical Corporation | 2011 | 5 |
| +1 | K102279 | INCU I | Atom Medical Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K021809 | V-2100G Advanced Infant IncubatorSummary page 1…Z, Class II Anesthesiology 21 CFR 870.2700 Oximeter, DQA, Class II Performance Standards: None applicable Predicate Device: K021809 V-2100G Infant Incubator K002355 V-505 Atom Infa Warmer K990966 Masimo Set Pulse Oximeter… | 2002 |
| * | K002355 | Atom Infa Warmer V-505Summary page 1…21 CFR 870.2700 Oximeter, DQA, Class II Performance Standards: None applicable Predicate Device: K021809 V-2100G Infant Incubator K002355 V-505 Atom Infa Warmer K990966 Masimo Set Pulse Oximeter Page 55 of 56 === Page… | 2000 |
| * | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor…Summary page 1…Class II Performance Standards: None applicable Predicate Device: K021809 V-2100G Infant Incubator K002355 V-505 Atom Infa Warmer K990966 Masimo Set Pulse Oximeter Page 55 of 56 Device Description This product c… | 1999 |
What descends from it? (4)
3 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K102710 (Atom Medical Corporation, 2010) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K021809.
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-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. Optional functions include pulse oximetry and oxygen delivery.
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.
https://510kreport.com/device/K061856 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061856: V-2200 Infant Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061856
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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