510(k) · Cleared

Cleared

VORTRAN Manometer

K153733510(k) TraditionalCleared Sep 16, 2016263-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 16, 2016 as substantially equivalent to K954486 (Mercury Medical, 1996) and 2 other predicates after a 263-day review. Its family tree reaches back 1 generation to 1996.

Decided: Sep 16, 2016
Review: 263 days
Class: Class II
Product code: CAP
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K954486 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK954486 Mercury Airway Pressure ManometerMercury Medical · 1996
This deviceK153733 VORTRAN ManometerVortran Medical Technology 1, Inc. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954486	Mercury Airway Pressure Manometer	Mercury Medical	1996	—
0 (this device)	K153733	VORTRAN Manometer	Vortran Medical Technology 1, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2004	1	0

FIG. 1 — Lineage of K153733, 1996–2016Source: 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

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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
*	K954486	Mercury Airway Pressure Manometer Summary page 4 …II Product Code: CAP Classification Advisory Committee: Anesthesiology Review Advisory Committee: Anesthesiology III. PREDICATE DEVICE K954486 Mercury Medical® Disposable Airway Pressure Manometer K040991 Ambu® Disposable Pressure Manometer K…	Mercury Medical	1996	—
*	K040991	Ambu Disposable Pressure Manometer Summary page 4 …esiology Review Advisory Committee: Anesthesiology III. PREDICATE DEVICE K954486 Mercury Medical® Disposable Airway Pressure Manometer K040991 Ambu® Disposable Pressure Manometer K003497 DPM™ – Disposable Pressure Monitor K041473 VORTR…	Ambu, Inc.	2004	—
*	K003497	Disposable Pressure Monitor Summary page 4 …III. PREDICATE DEVICE K954486 Mercury Medical® Disposable Airway Pressure Manometer K040991 Ambu® Disposable Pressure Manometer K003497 DPM™ – Disposable Pressure Monitor K041473 VORTRAN Automatic Resuscitator (VAR-Plus)…	Engineered Medical Systems	2000	—
†	K041473	Var-Plus (Vortran Automatic Resuscitator), Model PCM	Vortran Medical Technology 1, Inc.	2004	2
†	K003684	Percussiveneb, Model PN-2001	Vortran Medical Technology 1, Inc.	2001	—
†	K920443	Minineb	Vortran Medical Technology 1, Inc.	1992	—

Also cleared against K954486: 2 other devices →

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?

None of the 3 ancestors has a recall.
2 other devices also cite its predicate K954486.

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. 2016, 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 Manometer is a single patient use device intended to provide visual indication of a patient’s airway pressure during ventilation from 0 to 60 cm-H2O. It may be attached to the manometer port on ventilation devices such as resuscitators, resuscitation bags, hyperinflation bags, CPAP Masks or CPAP Circuits.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K153733 · printed Nov 4, 2026

Cite this page

510(k) Report. “K153733: VORTRAN Manometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153733

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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