510(k) · Cleared
ClearedEms Mouth to Mask Resuscitators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Medical Systems · CBP Valve, Non-Rebreathing
Cleared on Apr 7, 1999 as substantially equivalent to K881086 (Lifeguard Medical Products, Inc., 1988) and 2 other predicates after a 154-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Apr 7, 1999
- Review
- 154 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K871407 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK871407 Meconium AspiratorIntertech Resources, Inc. · 1987
- This deviceK983919 Ems Mouth to Mask ResuscitatorsEngineered Medical Systems · 1999
- Descendant · cites it directly · 0 of its ownK171961 Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen…Xiamen Compower Medical Tech. Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower…Xiamen Compower Medical Tech. Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871407 | Meconium Aspirator | Intertech Resources, Inc. | 1987 | — |
| 0 (this device) | K983919 | Ems Mouth to Mask Resuscitators | Engineered Medical Systems | 1999 | — |
| +1 | 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 |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K881086 | Lifeguard Mouth to Mask ResuscitatorSummary page 1…é;lé:;rcsuscitators Classification Name: Non-rebreéti?if;é valve Device: EMS Mou'tli?tdlMask resuscitators Predicate Devices: EMS Mou:tl;. t‘c-SIiMask resuscitators - K881086 Formosa cj Health Pastners - CPR Super - K953230 Intertech - MTM - K871407 The EMS Mouth to Mask resuscitators are a combiigati… | 1988 |
| * | K953230 | CPR Super Pocket PackSummary page 1…eéti?if;é valve Device: EMS Mou'tli?tdlMask resuscitators Predicate Devices: EMS Mou:tl;. t‘c-SIiMask resuscitators - K881086 Formosa cj Health Pastners - CPR Super - K953230 Intertech - MTM - K871407 The EMS Mouth to Mask resuscitators are a combiigation of components wnich Include a favw uask, one wa… | 1996 |
| * | K871407 | Meconium AspiratorSummary page 1…MS Mou'tli?tdlMask resuscitators Predicate Devices: EMS Mou:tl;. t‘c-SIiMask resuscitators - K881086 Formosa cj Health Pastners - CPR Super - K953230 Intertech - MTM - K871407 The EMS Mouth to Mask resuscitators are a combiigation of components wnich Include a favw uask, one way valve, filter and mouthp… | 1987 |
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 |
|---|---|---|---|
| K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower… | 2017 | 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K171961 (Xiamen Compower Medical Tech. Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Indicated to provide assisted ventilation to someone requiring assisted ventilation, breathing or resuscitation, by use of a mouth to mask method. Patient population is child / infant and adult.
Those with oxygen port are prescription devices and those without the oxygen port are OTC.
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/K983919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983919: Ems Mouth to Mask Resuscitators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983919
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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