510(k) · Cleared
ClearedSmart Bag MO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O-Two Systems International, Inc. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Jun 26, 2003 as substantially equivalent to K973419 (Nellcor Puritan Bennett, Inc., 1998) after a 426-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Jun 26, 2003
- Review
- 426 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K894053 (1989). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK894053 2ND Modification of Fef (TM) End-Tidal CO2 DetectorFenem, Inc. · 1989
- 2 generations backK960468 DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc. · 1996
- 1 generation backK973419 DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc. · 1998
- This deviceK021328 Smart Bag MOO-Two Systems International, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK212905 Sotair DeviceSafe Bvm Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K212905Sotair DeviceSafe Bvm Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894053 | 2ND Modification of Fef (TM) End-Tidal CO2 Detector | Fenem, Inc. | 1989 | — |
| −2 | K960468 | DMR/CO2 Combo Kti | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −1 | K973419 | DMR Plus Disposable Manual Resuscitator | Nellcor Puritan Bennett, Inc. | 1998 | — |
| 0 (this device) | K021328 | Smart Bag MO | O-Two Systems International, Inc. | 2003 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 |
|---|---|---|---|
| * | K973419 | DMR Plus Disposable Manual ResuscitatorSummary page 1…ITATOR REGULATORY CLASS: II 510K # : LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED: DMR Plus Disposable Manual Resuscitator - 510K #: K973419 DESCRIPTION OF THE DEVICE: The SMART BAG"M0 is a manual resuscitator comprising a self inflating bag, a one way valve and a fac… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212905 | Sotair Device | 2022 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K212905 (Safe Bvm Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K973419.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SMART BAG@MD is intended for manual ventilation of patients using ambient air or supplemental oxygen supplied from an oxygen source. The SMART BAG@MD is available in a child and an adult size. The SMART BAG@MD is available with components that can be autoclaved, or can be chemically disinfected. A single use disposable version is also available. The SMART BAG@Mo includes a flow limiting valve that limits the inspiratory flow to approximately 40…
Read the full statement (116 words)
The SMART BAG@MD is intended for manual ventilation of patients using ambient air or supplemental oxygen supplied from an oxygen source. The SMART BAG@MD is available in a child and an adult size. The SMART BAG@MD is available with components that can be autoclaved, or can be chemically disinfected. A single use disposable version is also available. The SMART BAG@Mo includes a flow limiting valve that limits the inspiratory flow to approximately 40 litres per minute, for the adult version and 30 litres per minute for the child version. The flow limiting valve is intended to minimize gastric inflation during manual ventilation. The flow limiting valve can be disabled to permit conventional operation of the resuscitator
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021328: Smart Bag MO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021328
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