Cleared Traditional

K012199 - DIGICAP

K012199 is an FDA 510(k) clearance for DIGICAP, manufactured by Humana USA, Inc.. The device is a Class 1 General Hospital device with product code GAB cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K012199 · Humana USA, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
159d
Days
Class 1
Risk

K012199 is an FDA 510(k) clearance for the DIGICAP. Classified as Needle, Suturing, Disposable (product code GAB), Class I - General Controls.

Submitted by Humana USA, Inc. (Bethesda, US). The FDA issued a Cleared decision on December 19, 2001 after a review of 159 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4800 - 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.

FDA 510(k) Submission Details - K012199

510(k) Number K012199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2001
Decision Date December 19, 2001
Days to Decision 159 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 129d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

GAB Device Classification - Class 1, General Controls

Product Code GAB Needle, Suturing, 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 - GAB Needle, Suturing, Disposable

All 7
Devices cleared under the same product code (GAB) and FDA review panel - the closest regulatory comparables to K012199.
AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
K980988 · Axya Medical, Inc. · May 1998
ENDO-JUDGE
K932591 · Synergistic Medical Technologies, Inc. · Dec 1993
CONTRAST BACKGROUND MATERIAL
K895681 · Applied Medical Technologies · Oct 1989
COATED SUTURE NEEDLE
K863595 · Sharpoint, Inc. · Oct 1986
ANCHOR BRAND SURGICAL NEEDLES
K831648 · Anchor Products Co. · Aug 1983
RADIATION STERILIZATION FOR NEEDLE CNTR
K812444 · Devon Industries, Inc. · Dec 1981
K012199 · DIGICAP
Download PDF FDA Summary Humana USA, Inc.