510(k) · Cleared
ClearedVortran GO2VENT
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 Apr 10, 2017 as substantially equivalent to K041473 (Vortran Medical Technology 1, Inc., 2004) after a 168-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Apr 10, 2017
- Review
- 168 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944349 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK944349 Oxylator EM-100Cpr Medical Devices, Inc. · 1995
- 1 generation backK041473 Var-Plus (Vortran Automatic Resuscitator), Model PCMVortran Medical Technology 1, Inc. · 2004 · Recalled
- This deviceK162968 Vortran GO2VENTVortran Medical Technology 1, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK202219 VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 |
| 0 (this device) | K162968 | Vortran GO2VENT | Vortran Medical Technology 1, Inc. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K041473 | Var-Plus (Vortran Automatic Resuscitator), Model PCMSummary page 4…s: II Product Code: BTL Classification Advisory Committee: Anesthesiology Review Advisory Committee: Anesthesiology III. PREDICATE DEVICE K041473 VORTRAN® Automatic Resuscitator (VAR-Plus) (Primary Predicate Device) K153733… | 2004 |
| † | K153733 | VORTRAN Manometer | 2016 |
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 |
|---|---|---|---|
| K202219 | VORTRAN GO2VENT with PEEP Valve | 2021 | 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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K202219 (Vortran Medical Technology 1, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K041473.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
This Device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162968: Vortran GO2VENT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162968
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