510(k) · Cleared
ClearedDispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galemed Corp. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Oct 15, 2008 as substantially equivalent to K944301 (Hudson Respiratory Care, Inc., 1994) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1990. 6 later devices descend from it.
- Decided
- Oct 15, 2008
- Review
- 83 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902062 (1990). 2 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK902062 Peep ValveHudson Oxygen Therapy Sales Co. · 1990
- This deviceK082092 Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve…Galemed Corp. · 2008
- Descendant · cites it directly · 1 of its ownK170663 Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP…Foremount Enterprise Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK090317 Babi*Plus Bubble Pap ValveA Plus Medical · 2009
- Descendant · 2 generations on · 0 of its ownK210288 Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK133957 Disposable Adjustable Peep Valve MR Conditional UseGalemed Corp. · 2014
- Descendant · cites it directly · 0 of its ownK112852 Babi Plus Neonatal Resuscitation BagA Plus Medical · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…Foremount Enterprise Co., Ltd. · 2018 · cites it directly1descendant
- K090317Babi*Plus Bubble Pap ValveA Plus Medical · 2009 · cites it directly1descendant
- K210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd. · 2021 · 2 generations on0descendants
- K133957Disposable Adjustable Peep Valve MR Conditional UseGalemed Corp. · 2014 · cites it directly0descendants
- K112852Babi Plus Neonatal Resuscitation BagA Plus Medical · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902062 | Peep Valve | Hudson Oxygen Therapy Sales Co. | 1990 | — |
| 0 (this device) | K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable… | Galemed Corp. | 2008 | — |
| +1 | K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve… | Foremount Enterprise Co., Ltd. | 2018 | — |
| +1 | K090317 | Babi*Plus Bubble Pap Valve | A Plus Medical | 2009 | — |
| +2 | K210288 | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | 2021 | — |
| +1 | K133957 | Disposable Adjustable Peep Valve MR Conditional Use | Galemed Corp. | 2014 | — |
| +1 | K112852 | Babi Plus Neonatal Resuscitation Bag | A Plus Medical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K944301 | Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360…Summary page 1…r with Disposable PEEP Valve Disposable PEEP Valve Predicate Devices: Ventilator, Emergency, Manual (Resuscitator): K944301: Hudson RCI, Temecula, CA (Teleflex Medical, Research Triangle Park, NC); LIFESAVER® Single patien… | 1994 |
| * | K902062 | Peep ValveSummary page 1…5364, 5365, 5366, 5367, 5369, 5370, 5371, 5372, 5373, 5377, 5380, 5387, and 5389. Attachment, Breathing, Positive End Expiratory: K902062: Hudson RCI, Temecula, CA (Teleflex Medical, Research Triangle Park, NC); LIFESAVER® PEEP Valve; C… | 1990 |
What descends from it? (6)
4 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 BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: < 10Kg, Child: - 23 Kg, Adult: >23 Kg Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: - 10 Kg, Child: - 23 Kg, Adult: > 23 Kg This manual resuscitator…
Read the full statement (155 words)
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:
Infant: < 10Kg, Child: - 23 Kg, Adult: >23 Kg
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:
Infant: - 10 Kg, Child: - 23 Kg, Adult: > 23 Kg
This manual resuscitator is supplied with a single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.
Single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency. and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082092 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082092: Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082092
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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