Cleared Traditional

K880534 - ZEPHYR

K880534 is the FDA 510(k) clearance for ZEPHYR by Racal Health & Safety, Inc.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K880534 · Racal Health & Safety, Inc. · General Hospital
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Sep 1988
Decision
210d
Days
Class 2
Risk

K880534 is an FDA 510(k) clearance for the ZEPHYR. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Racal Health & Safety, Inc. (Frederick, US). The FDA issued a Cleared decision on September 6, 1988 after a review of 210 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Racal Health & Safety, Inc. devices

Submission Details

510(k) Number K880534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date September 06, 1988
Days to Decision 210 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 129d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 409
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K880534.
TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK
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K910182 · 3M Company · Mar 1991
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · 3M Company · Mar 1989
ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
K881618 · 3M Company · May 1988
KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001
K875194 · Welch Allyn, Inc. · Jan 1988
TWO-PLY PAPER FACE FACE MASK
K832281 · Abco Dealers, Inc. · Aug 1983