Cleared Traditional

K872895 - HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. (FDA 510(k) Clearance)

Class I Anesthesiology device.

K872895 · Haemonetics Corp. · Anesthesiology device
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Jan 1988
Decision
172d
Days
Class 1
Risk

K872895 is an FDA 510(k) clearance for the HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.. Classified as Laryngoscope, Non-rigid (product code CAL), Class I - General Controls.

Submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on January 11, 1988 after a review of 172 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5530 - 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.

View all Haemonetics Corp. devices

Submission Details

510(k) Number K872895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1987
Decision Date January 11, 1988
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 139d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAL Laryngoscope, Non-rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5530
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.