Cleared Traditional

K913791 - OHMEDA 7800 ANESTHESIA VENTILATOR

K913791 is the FDA 510(k) clearance for OHMEDA 7800 ANESTHESIA VENTILATOR by Ohmeda Anesthesia Systems Therapy Group. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 594-day FDA review.

K913791 · Ohmeda Anesthesia Systems Therapy Group · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
594d
Days
Class 2
Risk

K913791 is an FDA 510(k) clearance for the OHMEDA 7800 ANESTHESIA VENTILATOR. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Ohmeda Anesthesia Systems Therapy Group (Madison, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 594 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Ohmeda Anesthesia Systems Therapy Group devices

Submission Details

510(k) Number K913791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1991
Decision Date April 08, 1993
Days to Decision 594 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
454d slower than avg
Panel avg: 140d · This submission: 594d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BSZ Gas-machine, Anesthesia

All 67
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K913791.
MAC/IV SEDATION KIT
K935546 · Vital Signs, Inc. · Jun 1994
NARKOMED 2C ANESTHESIA SYSTEM
K930351 · Draeger Medical, Inc. · Jun 1993
OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
K921742 · Ohmeda Medical · May 1993
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K905635 · Ohmeda Medical · May 1991
OHMEDA UNIVERSAL PAC
K901117 · Ohmeda Medical · Sep 1990
NARKOMED 4 ANESTHESIA SYSTEM
K901713 · Draeger Medical, Inc. · Jul 1990