Cleared Traditional

K810076 - PHERESIS NEEDLE ASSEMBLY

K810076 is an FDA 510(k) clearance for PHERESIS NEEDLE ASSEMBLY, manufactured by Haemonetics Corp.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K810076 · Haemonetics Corp. · General & Plastic Surgery device
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Mar 1981
Decision
51d
Days
Class 1
Risk

K810076 is an FDA 510(k) clearance for the PHERESIS NEEDLE ASSEMBLY. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Haemonetics Corp. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1981 after a review of 51 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Haemonetics Corp. devices

FDA 510(k) Submission Details - K810076

510(k) Number K810076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date March 05, 1981
Days to Decision 51 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GAA Needle, Aspiration And Injection, Disposable

All 46
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K810076.
HYPODERMIC NEEDLES & SYRINGES
K821348 · Medi-Tech, Inc. · Jun 1982
CUATICO MYELOGRAPHY NEEDLES
K813367 · Dlp, Inc. · Jan 1982
DISPOSABLE CHIBA-TYPE NEEDLE
K813368 · Dlp, Inc. · Jan 1982
ACCU-CORE DISPOSABLE BIOPSY NEEDLE
K801457 · Medline Industries, Inc. · Jul 1980
BURRON VENTED NEEDLE
K790472 · National Patent Development Corp. · Mar 1979
NEEDLE II, BURRON FILTER
K790060 · National Patent Development Corp. · Mar 1979