Cleared Traditional

DIGICAP (K012199) - FDA 510(k) Clearance

Class I General Hospital device.

K012199 · Humana USA, Inc. · General Hospital
Download Printable Device Report (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.

View all Humana USA, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 129d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.