510(k) · Cleared
ClearedEms Peep Valves- Adjustable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Medical Systems · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Jan 22, 1999 as substantially equivalent to K932799 (Engineered Medical Systems, 1993) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 1993. 12 later devices descend from it.
- Decided
- Jan 22, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923976 (1993). 2 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923976 Ambu Single Patient Use Peep ValveAmbu, Inc. · 1993
- This deviceK983920 Ems Peep Valves- AdjustableEngineered Medical Systems · 1999
- Descendant · cites it directly · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
- Descendant · 3 generations on · 3 of its ownK122130 Winx Sleep Therapy SystemApnicure, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK090398 Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 2 of its ownK130538 Winx Sleep Therapy SystemApnicure, Inc. · 2013
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · cites it directly10descendants
- K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012 · 2 generations on5descendants
- K122130Winx Sleep Therapy SystemApnicure, Inc. · 2012 · 3 generations on3descendants
- K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · 2 generations on3descendants
- K130538Winx Sleep Therapy SystemApnicure, Inc. · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923976 | Ambu Single Patient Use Peep Valve | Ambu, Inc. | 1993 | — |
| 0 (this device) | K983920 | Ems Peep Valves- Adjustable | Engineered Medical Systems | 1999 | — |
| +1 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| +2 | K111549 | Attune Sleep Apnea System | Apnicure, Inc. | 2012 | — |
| +3 | K122130 | Winx Sleep Therapy System | Apnicure, Inc. | 2012 | — |
| +2 | K090398 | Provent Professional Sleep Apnea Therapy | Ventus Medical, Inc. | 2009 | 1 |
| +3 | K130538 | Winx Sleep Therapy System | Apnicure, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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 BYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K932799 | Single Use Manual Resuscitator Peep ValveSummary page 1…Common/Usual Name: PEEP valve Classification Name: Breathing attachment - positive end expiratory pressure Device: EMS PEEP Valve Predicate Devices: EMS PEEP valve - K932799 Ambu - PEEP - K923976 Intertech - PEEP - K# unknown ( Device Description: The EMS PEEP valve is a adjustable valve which is pl… | 1993 |
| * | K923976 | Ambu Single Patient Use Peep ValveSummary page 1…EP valve Classification Name: Breathing attachment - positive end expiratory pressure Device: EMS PEEP Valve Predicate Devices: EMS PEEP valve - K932799 Ambu - PEEP - K923976 Intertech - PEEP - K# unknown ( Device Description: The EMS PEEP valve is a adjustable valve which is placed in circuit and pro… | 1993 |
| * | — | Intertech - PEEP Named without a submission number |
What descends from it? (12)
See all 122 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K071560 (Ventus Medical, Inc., 2008) has gone furthest, with 10 descendants of its own.
How does its category compare?
All BYE devicesBYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BYE
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · BYE
117in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYE
1in 2015
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BYE
7in 2025
MAUDE reports naming product code BYE, 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 | 1 | — | 4 | 8 |
| 2008 | 1 | — | 2 | 3 |
| 2009 | 3 | 155 | 0 | 1 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 1 | 4 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
Indicated as an accessory to provide positive end expiratory pressure breathing capabilities to manual resuscitator, therapeutic CPAP systems, ventilator circuits. Available in 19mm, 22mm and 30 mm fittings. Pressure range from 0 to 20 cm H₂O
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/K983920 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983920: Ems Peep Valves- Adjustable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983920
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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