510(k) Report

510(k) · Cleared

Cleared

Operating Room Ventilator

K770084510(k) TraditionalCleared Feb 23, 197740-day reviewClass II21 CFR 878.5070

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

Dupaco, Inc. · FZH Apparatus, Air Handling, Room

Cleared on Feb 23, 1977 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 23, 1977
Review
40 days
Class
Class II
Product code
FZH
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K770084Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Planning a device in FZH? 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 has not posted a summary or statement for it, so its predicates are not known.

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 FZH devices

FZH Apparatus, Air Handling, Room: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZH

FDA has decided no FZH device since 2007.

Median 510(k) review, days · FZH

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

Recalls per year · FZH

No recall names FZH since 2007.

Adverse event reports per year · FZH

10in 2022

2019: 12022: 10
2007high 10 (2022) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—010
20230—00
20240—00
20250—00
20260—0—

More from Dupaco, Inc.

5 FDA decisions under this applicant name. See the company

  • K150518Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mmDupaco, Inc. · 2015
  • K841581Unifilter Anesthesia & Respiratory FiltDupaco, Inc. · 1984
  • K830395PeeperDupaco, Inc. · 1983
  • K821434Ekg (Ecg) ElectrodesDupaco, Inc. · 1982

Recent decisions in FZH

The FZH category page

  • K923233Cardio-Pak Laparotomy PackCardio-Med-Associates, Inc. · 19931 recall
  • K875305Model Uca / Spec System UcaSpec Systems, Inc. · 1988
  • K871901UltraflowCustom Industries, Inc. · 1987

https://510kreport.com/device/K770084 · printed Nov 5, 2026

Cite this page

510(k) Report. “K770084: Operating Room Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K770084

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026