510(k) · Cleared
ClearedVORTRAN GO2VENT with PEEP Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vortran Medical Technology 1, Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Feb 11, 2021 as substantially equivalent to K162968 (Vortran Medical Technology 1, Inc., 2017) after a 189-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Feb 11, 2021
- Review
- 189 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944349 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK944349 Oxylator EM-100Cpr Medical Devices, Inc. · 1995
- 2 generations backK041473 Var-Plus (Vortran Automatic Resuscitator), Model PCMVortran Medical Technology 1, Inc. · 2004 · Recalled
- 1 generation backK162968 Vortran GO2VENTVortran Medical Technology 1, Inc. · 2017
- This deviceK202219 VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944349 | Oxylator EM-100 | Cpr Medical Devices, Inc. | 1995 | — |
| −2 | K041473 | Var-Plus (Vortran Automatic Resuscitator), Model PCM | Vortran Medical Technology 1, Inc. | 2004 | 2 |
| −1 | K162968 | Vortran GO2VENT | Vortran Medical Technology 1, Inc. | 2017 | — |
| 0 (this device) | K202219 | VORTRAN GO2VENT with PEEP Valve | Vortran Medical Technology 1, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 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 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? (1)
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 |
|---|---|---|---|
| * | K162968 | Vortran GO2VENTSummary page 4…Classification Name: Ventilator, Emergency, Powered (Resuscitator) (21 CFR 868.5925) Regulatory Class: II Product Code: BTL, BYE III. PREDICATE DEVICE VORTRAN GO2VENT, K162968 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEVICE D… | 2017 |
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 26 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The VORTRAN G02VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202219: VORTRAN GO2VENT with PEEP Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202219
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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