510(k) · Cleared

Cleared

Modification to Ventlab Hyperinflation Bag System

K020281510(k) SpecialCleared Feb 11, 200214-day reviewClass II21 CFR 868.5905

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

Ventlab Corp. · NHK Resuscitator, Manual, Non Self-Inflating

Cleared on Feb 11, 2002 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Feb 11, 2002
Review: 14 days
Class: Class II
Product code: NHK
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K020281Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NHK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

How does its category compare?

All NHK devices

NHK Resuscitator, Manual, Non Self-Inflating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHK

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHK

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

Recalls per year · NHK

No recall names NHK since 2007.

Adverse event reports per year · NHK

2in 2025

2007high 32 (2015) · low 0 (2007)2025

MAUDE reports naming product code NHK, 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	0	—	2
2009	1	—	1
2010	0	—	2
2011	0	—	2
2012	0	—	3
2013	0	—	4
2014	0	—	15
2015	0	—	32
2016	0	—	7
2017	0	—	5
2018	0	—	3
2019	0	—	6
2020	0	—	1
2021	0	—	7
2022	0	—	7
2023	0	—	8
2024	0	—	6
2025	0	—	2
2026	0	—	—

What is it indicated for?

Read the full statement (116 words)

Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyperventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a built-in: ". manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve.

Federal (USA) law restricts this device to sale by or on the order of a physician.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K020281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020281: Modification to Ventlab Hyperinflation Bag System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020281

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026