510(k) · Cleared
ClearedV-505 Infa Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atom Medical, Inc. · FMT Warmer, Infant Radiant
Cleared on Apr 28, 2006 as substantially equivalent to K940951 (Air-Shields, Inc., 1995) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Apr 28, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- FMT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940951 (1995). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK940951 RW Resucitaire Infant Radiant WarmerAir-Shields, Inc. · 1995
- This deviceK060461 V-505 Infa WarmerAtom Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK103317 Resuscitation Unit 105Atom Medical Corporation · 2011
- Descendant · cites it directly · 0 of its ownK102227 Infa Warmer IAtom Medical Corporation · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940951 | RW Resucitaire Infant Radiant Warmer | Air-Shields, Inc. | 1995 | — |
| 0 (this device) | K060461 | V-505 Infa Warmer | Atom Medical, Inc. | 2006 | — |
| +1 | K103317 | Resuscitation Unit 105 | Atom Medical Corporation | 2011 | — |
| +1 | K102227 | Infa Warmer I | Atom Medical Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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 FMT? 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 FMT device
- #1 K243606 Babyroo TN300score 9.3 · 3 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 |
|---|---|---|---|
| * | K940951 | RW Resucitaire Infant Radiant WarmerSummary page 1…ation: General Hospital 21 CFR 880.5130 Infant Radiant Warmer, FMT, Class II Performance Standards: None applicable Predicate Device: K940951 Resuscitaire Infant Radiant Warmer K002355 V-505 Infa Warmer Device Description The Atom Infa Warmer V-505 is designed to… | 1995 |
| * | K002355 | Atom Infa Warmer V-505Summary page 1…130 Infant Radiant Warmer, FMT, Class II Performance Standards: None applicable Predicate Device: K940951 Resuscitaire Infant Radiant Warmer K002355 V-505 Infa Warmer Device Description The Atom Infa Warmer V-505 is designed to maintain an infants body temperature by means of i… | 2000 |
What descends from it? (2)
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?
How does its category compare?
All FMT devicesFMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMT
103in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMT
4in 2019
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · FMT
359in 2025
MAUDE reports naming product code FMT, 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 | 2 | — | 0 | 21 |
| 2008 | 0 | — | 1 | 114 |
| 2009 | 1 | — | 2 | 80 |
| 2010 | 1 | — | 0 | 106 |
| 2011 | 1 | — | 0 | 79 |
| 2012 | 4 | 103 | 0 | 54 |
| 2013 | 1 | — | 2 | 55 |
| 2014 | 0 | — | 1 | 79 |
| 2015 | 0 | — | 1 | 56 |
| 2016 | 0 | — | 1 | 56 |
| 2017 | 0 | — | 0 | 46 |
| 2018 | 1 | — | 4 | 79 |
| 2019 | 0 | — | 4 (4) | 1,437 |
| 2020 | 2 | — | 0 | 1,605 |
| 2021 | 1 | — | 0 | 473 |
| 2022 | 1 | — | 0 | 153 |
| 2023 | 1 | — | 0 | 175 |
| 2024 | 0 | — | 0 | 257 |
| 2025 | 1 | — | 0 | 359 |
| 2026 | 0 | — | 2 (2) | — |
What is it indicated for?
The V-505 Atom Infa Warmer is a radiant warming, open type incubator intended to provide an optimum clinical environment for observation, examination, temperature regulation, and management of neonates. Optional functions include pulse oximetry and oxygen delivery.
This device is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060461: V-505 Infa Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060461
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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