510(k) · Cleared
ClearedSotair Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safe Bvm Corporation · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Aug 18, 2022 as substantially equivalent to K021328 (O-Two Systems International, Inc., 2003) after a 339-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Aug 18, 2022
- Review
- 339 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894053 (1989). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK894053 2ND Modification of Fef (TM) End-Tidal CO2 DetectorFenem, Inc. · 1989
- 3 generations backK960468 DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc. · 1996
- 2 generations backK973419 DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc. · 1998
- 1 generation backK021328 Smart Bag MOO-Two Systems International, Inc. · 2003
- This deviceK212905 Sotair DeviceSafe Bvm Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894053 | 2ND Modification of Fef (TM) End-Tidal CO2 Detector | Fenem, Inc. | 1989 | — |
| −3 | K960468 | DMR/CO2 Combo Kti | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −2 | K973419 | DMR Plus Disposable Manual Resuscitator | Nellcor Puritan Bennett, Inc. | 1998 | — |
| −1 | K021328 | Smart Bag MO | O-Two Systems International, Inc. | 2003 | — |
| 0 (this device) | K212905 | Sotair Device | Safe Bvm Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 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 BTM? 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 BTM device
- #1 K243861 butterflyBVMscore 9.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K021328 | Smart Bag MOSummary page 4…ator Device Class: Class 2 Device Code: BTM Review Panel: Anesthesiology 3. Predicate Device: Smart Bag MO (K021328), O-Two Systems International, Inc. No reference devices were used in this submission 4. Device Description: The Sota… | 2003 |
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 33 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · BTM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTM
83in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTM
9in 2024
Class I (24 since 2007) Class II/III not classified
Adverse event reports per year · BTM
36in 2025
MAUDE reports naming product code BTM, 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 | 65 |
| 2008 | 3 | 83 | 0 | 31 |
| 2009 | 0 | — | 23 | 21 |
| 2010 | 2 | — | 3 | 23 |
| 2011 | 2 | — | 0 | 48 |
| 2012 | 1 | — | 13 (13) | 69 |
| 2013 | 0 | — | 3 (1) | 44 |
| 2014 | 0 | — | 0 | 108 |
| 2015 | 1 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 92 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 2 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 9 | 46 |
| 2024 | 0 | — | 9 (9) | 33 |
| 2025 | 2 | — | 0 | 36 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The Sotairm device is intended for use with a manual resuscitator with air-tight connections, in non-breathing patients that require flow controlled ventilation using ambient air or a supplemental oxygen source. The Sotair device is a single use, disposable device added to a manual resuscitator and can be used for in-hospital, emergency, and transport care. The adult Sotair device comprises a flow-limiting valve that limits the inspiratory flow enabling…
Read the full statement (115 words)
The Sotairm device is intended for use with a manual resuscitator with air-tight connections, in non-breathing patients that require flow controlled ventilation using ambient air or a supplemental oxygen source. The Sotair device is a single use, disposable device added to a manual resuscitator and can be used for in-hospital, emergency, and transport care. The adult Sotair device comprises a flow-limiting valve that limits the inspiratory flow enabling providers to ventilate approximately 55 liters-per-minute (LPM). The flow-limiting valve is intended to minimize gastric inflation during manual ventilation. The Sotair device can be disabled by removing the device, thereby returning the manual resuscitator to its conventional operation. The Sotair device is intended for adult use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212905: Sotair Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212905
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