Cleared Traditional

K882953 - HYDRAMED BY LECHLER

K882953 is an FDA 510(k) clearance for HYDRAMED BY LECHLER, manufactured by Lechler, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K882953 · Lechler, Inc. · Anesthesiology device
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Oct 1988
Decision
90d
Days
Class 2
Risk

K882953 is an FDA 510(k) clearance for the HYDRAMED BY LECHLER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Lechler, Inc. (St. Charles, US). The FDA issued a Cleared decision on October 12, 1988 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 - K882953

510(k) Number K882953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1988
Decision Date October 12, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 466
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K882953.
UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.
K884359 · Automatic Liquid Packaging, Inc. · Dec 1988
OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · Nidek, Inc. · Dec 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988
MICROCIRRUS MEDICAL NEBULIZER
K881935 · Dhd Medical Products Div. Diemolding Corp. · Jun 1988
INSPIRON NEBULO BASIC EXTERNAL HEATER
K880304 · Intertech Resources, Inc. · Mar 1988
BRONCHODILATOR TEE - 9056 SERIES
K873521 · Boehringer Laboratories · Mar 1988
K882953 · HYDRAMED BY LECHLER
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