Cleared Traditional

K790039 - COUNTER

K790039 is an FDA 510(k) clearance for COUNTER, manufactured by Anago, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K790039 · Anago, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1979
Decision
9d
Days
Class 2
Risk

K790039 is an FDA 510(k) clearance for the COUNTER, DISPOSABLE SURGICAL NEEDLE. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Anago, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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: 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 Anago, Inc. devices

FDA 510(k) Submission Details - K790039

510(k) Number K790039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1979
Decision Date January 17, 1979
Days to Decision 9 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 129d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMK Device Classification - Class 2, Special Controls

Product Code MMK Container, Sharps
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - MMK Container, Sharps

All 39
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K790039.
DISPOSABLE NEEDLE COUNTER (20-560)
K861319 · Anago, Inc. · May 1986
SHARP COLLECTION SYSTEM-SHARP-A-GATOR
K844654 · Devon Industries, Inc. · Dec 1984
PROTECTOR II
K790661 · Richard-Allan Medical Ind., Inc. · Apr 1979
BOARD, DISPOSABLE CONTROL COUNT
K781791 · Dexide, Inc. · Nov 1978
PROTECTOR
K771611 · Richard-Allan Medical Ind., Inc. · Sep 1977