Cleared Traditional

K896300 - LDW SPIROMETRY SYSTEM

K896300 is an FDA 510(k) clearance for LDW SPIROMETRY SYSTEM, manufactured by Lanpher Diagnostic Workstations, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K896300 · Lanpher Diagnostic Workstations, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
155d
Days
Class 2
Risk

K896300 is an FDA 510(k) clearance for the LDW SPIROMETRY SYSTEM. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Lanpher Diagnostic Workstations, Inc. (Atherton, US). The FDA issued a Cleared decision on April 3, 1990 after a review of 155 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.

FDA 510(k) Submission Details - K896300

510(k) Number K896300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date April 03, 1990
Days to Decision 155 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
15d slower than avg
Panel avg: 140d · This submission: 155d
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 178
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K896300.
TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)
K900331 · Ghg Medizin-Elektronik AG · Sep 1990
SPIRO ANALYZER MODEL ST 250
K901308 · Futuremed Div. of Future Impex Corp. · Jul 1990
FUKUDA DENSHI MODEL SPIROSIFT 3000
K900391 · Fukuda Denshi USA, Inc. · Apr 1990
SERIAL FLOW
K900673 · Spirometrics, Inc. · Apr 1990
SPIROMETRICS MODEL 2600 MIRO SPIROMETER
K901057 · Spirometrics, Inc. · Apr 1990
SPIROSCAN 4000
K896924 · Brentwood Instruments, Inc. · Mar 1990
K896300 · LDW SPIROMETRY SYSTEM
Download PDF Lanpher Diagnostic Wo…