Cleared Traditional

K841657 - PATIENT TUBING HYTREL SIEMENS-ELEMA

K841657 is an FDA 510(k) clearance for PATIENT TUBING HYTREL SIEMENS-ELEMA, manufactured by Siemens Elema AB. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K841657 · Siemens Elema AB · Anesthesiology device
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May 1984
Decision
30d
Days
Class 1
Risk

K841657 is an FDA 510(k) clearance for the PATIENT TUBING HYTREL SIEMENS-ELEMA. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Siemens Elema AB (Mchenry, US). The FDA issued a Cleared decision on May 23, 1984 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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 - K841657

510(k) Number K841657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date May 23, 1984
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
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 - BZO Set, Tubing And Support, Ventilator (w Harness)

All 27
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K841657.
DISPOSABLE VENTILATOR CIRCUITS
K860879 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
VENTILATOR CIRCUITS (VARIOUS TYPES)
K860880 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
SAF T FLO VENTILATOR TUBING
K850703 · Bivona Medical Technologies · Mar 1985
VOLUME VENTILATOR CIRCUIT W/WATER TRAP
K834570 · Airlife, Inc. · Mar 1984
UNIVERSAL VOL. VENTILATOR 72 #1626
K832681 · Hudson Oxygen Therapy Sales Co. · Sep 1983
BE #16 - MANIFOLD
K823481 · Instrumentation Industries, Inc. · Dec 1982