510(k) · Cleared

Cleared

Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)- Pediatric

K103639510(k) TraditionalCleared Sep 15, 2011276-day reviewClass II21 CFR 868.2600

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vortran Medical Technology 1, Inc. · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Cleared on Sep 15, 2011 as substantially equivalent to K073261 (Vortran Medical Technology 1, Inc., 2008) and 2 other predicates after a 276-day review. Its family tree reaches back 3 generations to 1995.

Decided: Sep 15, 2011
Review: 276 days
Class: Class II
Product code: CAP
Recalls: None
Predicates: 3

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.

By dateBy generation

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 backK073261 Var MonitorVortran Medical Technology 1, Inc. · 2008
This deviceK103639 Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway…Vortran Medical Technology 1, Inc. · 2011

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	K073261	Var Monitor	Vortran Medical Technology 1, Inc.	2008	—
0 (this device)	K103639	Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor…	Vortran Medical Technology 1, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	1	0

FIG. 1 — Lineage of K103639, 1995–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 CAP? 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 CAP device

#1 K201666 Single Use Manometerscore 0.3 · 1 generation · no Class I recall

Get a 510(k) 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	Applicant	Decided	Recalls
*	K073261	Var Monitor Summary page 1 …siology Advisory Committee _______ 9. Review Anesthesiology Advisory Committee 10. Predicate VAR" with VAR-Monitor Tm 51 0(k) No.: K073261 Device VAR with Manometer 510(k) No.: K001430 VAR-Plus with Manometer 51 0(k) No.: K041473…	Vortran Medical Technology 1, Inc.	2008	—
*	K001430	Respirtech Pro-O2C, Model 2200 and Respirtech Pro, Model 2000 Summary page 1 …Anesthesiology Advisory Committee 10. Predicate VAR" with VAR-Monitor Tm 51 0(k) No.: K073261 Device VAR with Manometer 510(k) No.: K001430 VAR-Plus with Manometer 51 0(k) No.: K041473 ___ 11. Device The VAPM is a battery (9V…	Vortran Medical Technology 1, Inc.	2000	2
*	K041473	Var-Plus (Vortran Automatic Resuscitator), Model PCM Summary page 1 …e VAR" with VAR-Monitor Tm 51 0(k) No.: K073261 Device VAR with Manometer 510(k) No.: K001430 VAR-Plus with Manometer 51 0(k) No.: K041473 ___ 11. Device The VAPM is a battery (9VDC) operated, portable, self- Description contained devic…	Vortran Medical Technology 1, Inc.	2004	2

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 16 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
3 of the 5 ancestors have a recall of any class.

How does its category compare?

All CAP devices

CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · CAP

1in 2020

2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAP

Too few CAP 510(k)s in any year since 2007 to give a median.

Recalls per year · CAP

No recall names CAP since 2007.

Adverse event reports per year · CAP

2in 2025

2007high 11 (2023) · low 0 (2007)2025

MAUDE reports naming product code CAP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	0
2009	0	—	1
2010	1	—	0
2011	2	—	0
2012	1	—	3
2013	2	—	0
2014	1	—	0
2015	1	—	0
2016	1	—	0
2017	0	—	0
2018	1	—	0
2019	2	—	4
2020	1	—	1
2021	0	—	5
2022	0	—	6
2023	0	—	11
2024	0	—	11
2025	0	—	2
2026	0	—	—

What is it indicated for?

The VORTRAN Airway Pressure Monitor (VAPM) is to be used by properly trained personnel to monitor the delivery of emergency, shodt term, ventilatory suppodt to adult (using VAPM-3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric Model).

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/K103639 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103639: Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)- Pediatric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103639

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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