510(k) · Cleared
ClearedOxylator EM-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cpr Medical Devices, Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Apr 17, 1995 after a 223-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 17, 1995
- Review
- 223 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK944349 Oxylator EM-100Cpr Medical Devices, Inc. · 1995
- Descendant · cites it directly · 4 of its ownK041473 Var-Plus (Vortran Automatic Resuscitator), Model PCMVortran Medical Technology 1, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 1 of its ownK162968 Vortran GO2VENTVortran Medical Technology 1, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK073261 Var MonitorVortran Medical Technology 1, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK202219 VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK103639 Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway…Vortran Medical Technology 1, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K041473Var-Plus (Vortran Automatic Resuscitator), Model PCMVortran Medical Technology 1, Inc. · 2004 · cites it directly4descendants
- K162968Vortran GO2VENTVortran Medical Technology 1, Inc. · 2017 · 2 generations on1descendant
- K073261Var MonitorVortran Medical Technology 1, Inc. · 2008 · 2 generations on1descendant
- K202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc. · 2021 · 3 generations on0descendants
- K103639Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)-…Vortran Medical Technology 1, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944349 | Oxylator EM-100 | Cpr Medical Devices, Inc. | 1995 | — |
| +1 | K041473 | Var-Plus (Vortran Automatic Resuscitator), Model PCM | Vortran Medical Technology 1, Inc. | 2004 | 2 |
| +2 | K162968 | Vortran GO2VENT | Vortran Medical Technology 1, Inc. | 2017 | — |
| +2 | K073261 | Var Monitor | Vortran Medical Technology 1, Inc. | 2008 | — |
| +3 | K202219 | VORTRAN GO2VENT with PEEP Valve | Vortran Medical Technology 1, Inc. | 2021 | — |
| +2 | K103639 | Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor… | Vortran Medical Technology 1, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTL? 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 BTL device
- #1 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041473 | Var-Plus (Vortran Automatic Resuscitator), Model PCM | 2004 | 4 |
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?
- Of its descendants, K041473 (Vortran Medical Technology 1, Inc., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, 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 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K944349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944349: Oxylator EM-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944349
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026