Cleared Traditional

K894667 - MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP

K894667 is an FDA 510(k) clearance for MODELS PB950 AND PB960 DATALOOP AND SPI..., manufactured by Pneumedics, Inc.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K894667 · Pneumedics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
86d
Days
Class 2
Risk

K894667 is an FDA 510(k) clearance for the MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Pneumedics, Inc. (Milford, US). The FDA issued a Cleared decision on October 19, 1989 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K894667

510(k) Number K894667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1989
Decision Date October 19, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 140d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 44
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K894667.
MODEL 508 PATIENT MONITOR
K921309 · Criticare Systems, Inc. · Dec 1993
PFM PROFESSIONAL 7000 SPIROMETER
K932278 · Advanced Medical Systems, Inc. · Dec 1993
VITALOGRAPH DATA STORAGE SPIROMETER
K930085 · Vitalograph , Ltd. · Jul 1993
L.A.P. SPIROMETER
K864836 · Timeter Instrument Corp. · Mar 1987
SPIROMETRY MODULE
K861486 · Medical Graphics Corp. · May 1986
VITALOGRAPH PFT PRINTER
K823683 · Vitalograph , Ltd. · Jan 1983
K894667 · MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
Download PDF Pneumedics, Inc.