510(k) · Cleared
Recalled · Class II · 2012Dual Incu I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atom Medical Corporation · FMZ Incubator, Neonatal
Cleared on Jan 4, 2011 as substantially equivalent to K061856 (Atom Medical, Inc., 2006) and 1 other predicate after a 148-day review. Its family tree reaches back 4 generations to 1997. 1 of the 12 devices in its family, counting itself, has a Class I recall. It has been recalled 5 times.
- Decided
- Jan 4, 2011
- Review
- 148 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 4 generations to K962603 (1997). 11 ancestors in all. No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 1 generation backK061856 V-2200 Infant IncubatorAtom Medical, Inc. · 2006
- This deviceK102226 Dual Incu IAtom Medical Corporation · 2011
Class I recalls in this family
- K020543 Ohmeda Medical Giraffe Omnibed2 generations back · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −1 | K061856 | V-2200 Infant Incubator | Atom Medical, Inc. | 2006 | — |
| 0 (this device) | K102226 | Dual Incu I | Atom Medical Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 2 | 1 |
| 2007 | 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 |
|---|---|---|---|
| * | K061856 | V-2200 Infant IncubatorSummary page 2…ator Classification Regulation: 880.5400 Panel: General Hospital Product Code: FMZ Predicate Device Information: Device Name: V-2200 Infant Incubator 5 10(k) Reference: K061856 Manufacturer: Atom Medical Corporation Device Name: Ohmeda Medical Giraffe Omnibed 5 10(k) Reference: K(071175 Manufacturer: GE… | 2006 |
| * | K071175 | Ohmeda Medical Giraffe OmnibedSummary page 2…Device Name: V-2200 Infant Incubator 5 10(k) Reference: K061856 Manufacturer: Atom Medical Corporation Device Name: Ohmeda Medical Giraffe Omnibed 5 10(k) Reference: K(071175 Manufacturer: GE HEALTH-CARE Device Description: Dual lncu i (Atom Infant Incubator Model 100) is a combination of an infant inc… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2012 | Class II | Z-1945-2012 | Device Design | There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode. |
| Aug 23, 2011 | Not classified | Z-0340-2012 | Device Design | The caster with lock on the radiant-warming open type incubator may become loose or break. |
| Aug 23, 2011 | Not classified | Z-0337-2012 | Device Design | The caster with lock on the incubator or infant warmer may become loose or break. |
| Aug 23, 2011 | Not classified | Z-0339-2012 | Device Design | The caster with lock on the incubator may become loose or break. |
| Aug 23, 2011 | Not classified | Z-0338-2012 | Device Design | The caster with lock on the incubator may become loose or break. |
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.
- K020543Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K061856.
How does its category compare?
All FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Dual Incu i is a combination of an infant incubator and an infant warmer. The device can transition from one mode to the other on user's demand.
The Dual Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry and oxygen density controlling.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102226: Dual Incu I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102226
Report an extraction error
Are you the manufacturer?
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