Cleared Traditional

K914205 - PFF-1

K914205 is an FDA 510(k) clearance for PFF-1, manufactured by Cybermedic, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K914205 · Cybermedic, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
225d
Days
Class 2
Risk

K914205 is an FDA 510(k) clearance for the PFF-1. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Cybermedic, Inc. (Washington, US). The FDA issued a Cleared decision on May 1, 1992 after a review of 225 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Cybermedic, Inc. devices

FDA 510(k) Submission Details - K914205

510(k) Number K914205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1991
Decision Date May 01, 1992
Days to Decision 225 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 140d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 156
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K914205.
FLOWSCAN
K924413 · Electrocaine Medical System · May 1993
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
K922428 · Fukuda Denshi USA, Inc. · Jan 1993
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K920111 · Sensor Medics Corp. · Oct 1992
SENSORMEDICS MODEL 922 SPIROMETER
K920246 · Sensor Medics Corp. · Apr 1992
AIRWAY THERMISTOR
K914219 · Synectics-Dantec · Feb 1992
VITALOGRAPH SPIROTRAC III
K912412 · Vitalograph , Ltd. · Oct 1991