Cleared Traditional

K872895 - HAEMONETICS CELL SAVER MINI SAVER AUTO....

K872895 is an FDA 510(k) clearance for HAEMONETICS CELL SAVER MINI SAVER AUTO...., manufactured by Haemonetics Corp.. The device is a Class 1 Anesthesiology device with product code CAL cleared through the Traditional 510(k) pathway after a 172-day FDA review.

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

FDA 510(k) Submission Details - K872895

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 140d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

CAL Device Classification - Class 1, General Controls

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.

Regulatory Peers - CAL Laryngoscope, Non-rigid

Devices cleared under the same product code (CAL) and FDA review panel - the closest regulatory comparables to K872895.
FI-10M
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AO STYLET LARYNGOSCOPE, MODEL SLS-1
K791634 · American Optical Corp. · Sep 1979