Cleared Traditional

K925580 - OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD

K925580 is an FDA 510(k) clearance for OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPO..., manufactured by Ohmeda Anesthesia Systems Therapy Group. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K925580 · Ohmeda Anesthesia Systems Therapy Group · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
210d
Days
Class 2
Risk

K925580 is an FDA 510(k) clearance for the OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD. 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 June 2, 1993 after a review of 210 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ohmeda Anesthesia Systems Therapy Group devices

FDA 510(k) Submission Details - K925580

510(k) Number K925580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1992
Decision Date June 02, 1993
Days to Decision 210 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
70d slower than avg
Panel avg: 140d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

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 158
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K925580.
ARC
K934669 · Medelec , Ltd. · Apr 1994
NARKOMED 2C ANESTHESIA SYSTEM
K930351 · Draeger Medical, Inc. · Jun 1993
IDACARE ANESTHESIA MANAGEMENT WORKSTATIN
K930492 · Premier Anesthesia Systems · Jun 1993
OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
K921742 · Ohmeda Medical · May 1993
SENSOR GUI
K923519 · Hospitronic · Dec 1992
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K905635 · Ohmeda Medical · May 1991