510(k) · Cleared
ClearedV-808 Atom Transcapsule
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atom Medical, Inc. · FPL Incubator, Neonatal Transport
Cleared on Aug 29, 2006 as substantially equivalent to K941106 (Air-Shields, Inc., 1994) and 1 other predicate after a 134-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Aug 29, 2006
- Review
- 134 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962603 (1997). 4 ancestors in all, the oldest K941106 (1994). No later device cites it as a predicate yet.
- 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 deviceK061071 V-808 Atom TranscapsuleAtom Medical, Inc. · 2006
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) | K061071 | V-808 Atom Transcapsule | Atom Medical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 FPL? 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 FPL device
- #1 K220742 NxtGen Infant Transport Incubatorscore 4.3 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K941106 | Model TI500 Isolette Infant IncubatorSummary page 1…ubator, FPL, Class 1I Anesthesiology 21 CFR 870.2700 Oximeter, OQA, Class II Performance Standards: None applicable Predicate Device: K941 106 T1500 Transport Incubator K990966 Masimo Set Pulse Oximeter Page 54 of 55 === Page 2… | 1994 |
| * | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor…Summary page 1…y 21 CFR 870.2700 Oximeter, OQA, Class II Performance Standards: None applicable Predicate Device: K941 106 T1500 Transport Incubator K990966 Masimo Set Pulse Oximeter Page 54 of 55… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K941106.
How does its category compare?
All FPL devicesFPL Incubator, Neonatal Transport: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FPL
148in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPL
No recall names FPL since 2007.
Adverse event reports per year · FPL
3in 2024
MAUDE reports naming product code FPL, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 4 | 148 | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The V-808 Atom Transcapsule is a neonatal transport incubator. The incubator
is a device with a transparent hood intended to contain a premature infant or a
neonatal infant within the compartment covered by said hood and intended to
safely convey the infant accommodated in that compartment, providing the infant
with isolated environment from ambient air where temperature - controlled air is
supplied. The V-808 also provides oxygen monitoring and supply as well as an
integrated pulse oximetry capability.
This device is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061071: V-808 Atom Transcapsule.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061071
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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