Cleared Traditional

K843849 - PNEUMOSCREEN

K843849 is an FDA 510(k) clearance for PNEUMOSCREEN, manufactured by Erich Jaeger, Inc.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K843849 · Erich Jaeger, Inc. · Anesthesiology device
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Oct 1984
Decision
15d
Days
Class 2
Risk

K843849 is an FDA 510(k) clearance for the PNEUMOSCREEN. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Erich Jaeger, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 16, 1984 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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.

View all Erich Jaeger, Inc. devices

FDA 510(k) Submission Details - K843849

510(k) Number K843849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1984
Decision Date October 16, 1984
Days to Decision 15 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
125d faster than avg
Panel avg: 140d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 24
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K843849.
OXYSCREEN
K843860 · Erich Jaeger, Inc. · Dec 1984
AW TEST
K843848 · Erich Jaeger, Inc. · Nov 1984
APTA-BRONCHOSCREEN
K843852 · Erich Jaeger, Inc. · Nov 1984
PULMONARY FUNCTION LAB SYSTEM 1070
K822986 · Medical Graphics Corp. · Nov 1982
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF
K810751 · General Electric Co. · Apr 1981
INSPIRON PULMONARY FUNCTION ANALYZER
K802920 · C.R. Bard, Inc. · Feb 1981