510(k) · Cleared
ClearedCompower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xiamen Compower Medical Tech. Co., Ltd. · CBP Valve, Non-Rebreathing
Cleared on Nov 17, 2017 as substantially equivalent to K142764 (Hangzhou Jinlin Medical Appliances Co., Ltd., 2015) and 2 other predicates after a 140-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Nov 17, 2017
- Review
- 140 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K861401 (1986). 12 ancestors in all, the oldest K833748 (1983). No later device cites it as a predicate yet.
- Root · 4 generations backK861401 Laerdal Pocket MaskLaerdal Medical Corp. · 1986
- 3 generations backK081516 Medsource CPR Mask with & Without Oxygen PortMedsource International, LLC · 2008
- 2 generations backK112126 Genuine First Aid CPR MaskGenuine First Aid, LLC · 2011
- 1 generation backK142764 KYOLING CPR Mask with Oxygen Port and Without Oxygen PortHangzhou Jinlin Medical Appliances Co., Ltd. · 2015
- This deviceK171961 Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen…Xiamen Compower Medical Tech. Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K861401 | Laerdal Pocket Mask | Laerdal Medical Corp. | 1986 | — |
| −3 | K081516 | Medsource CPR Mask with & Without Oxygen Port | Medsource International, LLC | 2008 | — |
| −2 | K112126 | Genuine First Aid CPR Mask | Genuine First Aid, LLC | 2011 | — |
| −1 | K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | Hangzhou Jinlin Medical Appliances Co., Ltd. | 2015 | — |
| 0 (this device) | K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port… | Xiamen Compower Medical Tech. Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 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 CBP? 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 CBP device
- #1 K241366 QualityFlow O2 Series (QualityFLOW O2)…score 8.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen PortSummary page 8…lation Number: 868.5870 Product Code: CBP Panel: Anesthesiology III. PREDICATE/REFERENCE DEVICES Kyoling CPR Mask with Oxygen Port (Prescription Use) K142764 – Decision Date: July 9, 2015 Kyoling CPR Mask without Oxygen Port (Over the Counter Use) K142764 - Decision… | 2015 |
| * | K983919 | Ems Mouth to Mask ResuscitatorsSummary page 8…ounter Use) K142764 - Decision Date: July 9, 2015 Engineered Medical Systems Child/Infant Facemask with Non-Rebreathing Valve (Over the Counter Use) K983919 – Decision Date: April 7, 1999 (Primary Predicate) Laerdal Paediatric Pocket Mask (Model 820050) K023805 – Decision… | 1999 |
| * | K152521 | Seal Rite Non-Rebreathing ValveSummary page 8…Paediatric Pocket Mask (Model 820050) K023805 – Decision Date: February 11, 2003 (Reference Device) Seal Rite™ Non-Rebreathing Valve (Over the Counter Use) K152521 – Decision Date: June 3, 2016 IV. DEVICE DESCRIPTION Compower Emergency CPR masks with non-rebreathing valves are designe… | 2016 |
| † | K023805 | Laerdal Paediatric Pocket Mask, Model 820050 | 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 31 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · CBP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBP
129in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBP
No recall names CBP since 2007.
Adverse event reports per year · CBP
1in 2021
MAUDE reports naming product code CBP, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 3 | 129 | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use. The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims…
Read the full statement (214 words)
The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use.
The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask without Oxygen Port is intended for over-the-counter use.
The Infant CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The Infant CPR Mask is indicated for use on infants with body weight up to 10 kg (22 Ibs). The Infant CPR Mask is intended for over-the-counter use.
The Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the-counter use.
The Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the-counter use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171961: Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171961
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