510(k) · Cleared
ClearedForemount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foremount Enterprise Co., Ltd. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on May 11, 2018 as substantially equivalent to K082092 (Galemed Corp., 2008) and 1 other predicate after a 431-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- May 11, 2018
- Review
- 431 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902062 (1990). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK902062 Peep ValveHudson Oxygen Therapy Sales Co. · 1990
- 1 generation backK082092 Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve…Galemed Corp. · 2008
- This deviceK170663 Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP…Foremount Enterprise Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK210288 Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902062 | Peep Valve | Hudson Oxygen Therapy Sales Co. | 1990 | — |
| −1 | K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable… | Galemed Corp. | 2008 | — |
| 0 (this device) | K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve… | Foremount Enterprise Co., Ltd. | 2018 | — |
| +1 | K210288 | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep…Summary page 4…ories Device Name: Ventilator, Emergency, Manual (Resuscitator) Product Code: BTM Regulation #: 868.5915 Device Class: 2 Predicate: K082092 – GaleMed Dispo-Bag Manual Resuscitator and accessories including Ventilation Bag, Patient Valve, Intake Valves, Reservoir B… | 2008 |
| * | K122077 | ManometerSummary page 4…es including Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask and PEEP Valve Disposable Manometer Predicate: K122077 - Intersurgical – Airway Pressure Manometer Device Description: Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and… | 2013 |
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 |
|---|---|---|---|
| K210288 | Disposable Manual Resuscitator | 2021 | 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 28 years and passes through 3 companies; a new generation was cleared every 18.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K210288 (Xiamen Compower Medical Tech. Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K082092.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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: less than or equal to 10Kg, Child: less than or equal to 23 Kg, Adult: greater than 23 Kg This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer. The PEEP Valve is a single…
Read the full statement (152 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: less than or equal to 10Kg, Child: less than or equal to 23 Kg, Adult: greater than 23 Kg
This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer.
The PEEP Valve is 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. Intended for patients that the clinician has determined need PEEP.
The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient’s airway pressure during ventilation. The manometer is to be used with resuscitation systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170663: Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170663
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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