510(k) · Cleared
ClearedEmt-Cpap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emergency Medical Techology · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Jul 15, 2002 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Jul 15, 2002
- Review
- 66 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK021520 Emt-CpapEmergency Medical Techology · 2002
- Descendant · cites it directly · 7 of its ownK080692 Macs Cpap SystemAiron Corporation · 2008
- Descendant · 2 generations on · 4 of its ownK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- Descendant · 3 generations on · 2 of its ownK102649 Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK110119 Pressure ManometerNeoforce Group, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK093862 Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K080692Macs Cpap SystemAiron Corporation · 2008 · cites it directly7descendants
- K092085Ispira Resuscitation UnitNeoforce Group, Inc. · 2009 · 2 generations on4descendants
- K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011 · 3 generations on2descendants
- K110119Pressure ManometerNeoforce Group, Inc. · 2011 · 3 generations on1descendant
- K093862Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021520 | Emt-Cpap | Emergency Medical Techology | 2002 | — |
| +1 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| +2 | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| +3 | K102649 | Neopop Infant Resuscitator with Flow Meter | Neoforce Group, Inc. | 2011 | — |
| +3 | K110119 | Pressure Manometer | Neoforce Group, Inc. | 2011 | — |
| +1 | K093862 | Carevent Handheld Cpap System | O-Two Medical Technologies, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTL? 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 BTL device
- #1 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
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, K080692 (Airon Corporation, 2008) has gone furthest, with 7 descendants of its own.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, 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 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021520 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021520: Emt-Cpap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021520
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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