Cleared Traditional

K844040 - SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB

K844040 is an FDA 510(k) clearance for SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB, manufactured by Siemens Elema AB. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K844040 · Siemens Elema AB · Anesthesiology device
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Oct 1984
Decision
9d
Days
Class 1
Risk

K844040 is an FDA 510(k) clearance for the SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Siemens Elema AB (Schaumburg, US). The FDA issued a Cleared decision on October 25, 1984 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - 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 Siemens Elema AB devices

FDA 510(k) Submission Details - K844040

510(k) Number K844040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1984
Decision Date October 25, 1984
Days to Decision 9 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
131d faster than avg
Panel avg: 140d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

BYD Device Classification - Class 1, General Controls

Product Code BYD Condenser, Heat And Moisture (artificial Nose)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYD Condenser, Heat And Moisture (artificial Nose)

All 23
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K844040.
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F
K864095 · Gambro, Inc. · Feb 1987
AMERICAN PHARMASEAL HUMIDAIR CONDENSER
K854012 · American Pharmaseal Div. Ahsc · Dec 1985
SERVO HUMIDIFIER 153
K852601 · Siemens Elema AB · Jul 1985
PALL HEAT MOISTURE EXCHANGING FILTER
K834292 · Pall Biomedical Products Co. · Apr 1984
INLINE FOAM NOSE
K840398 · Mallinckrodt Critical Care · Mar 1984
FOAM NOSE
K840399 · Mallinckrodt Critical Care · Mar 1984