Cleared Traditional

K983468 - FASTTAKE ADAPTER, MODEL # P/N 020-072-01

K983468 is an FDA 510(k) clearance for FASTTAKE ADAPTER, manufactured by Selfcare, Inc.. The device is a Class 1 Chemistry device with product code JQP cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K983468 · Selfcare, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
77d
Days
Class 1
Risk

K983468 is an FDA 510(k) clearance for the FASTTAKE ADAPTER, MODEL # P/N 020-072-01. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Selfcare, Inc. (Waltham, US). The FDA issued a Cleared decision on December 17, 1998 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - the FDA in vitro diagnostics and chemistry 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 Selfcare, Inc. devices

FDA 510(k) Submission Details - K983468

510(k) Number K983468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1998
Decision Date December 17, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

JQP Device Classification - Class 1, General Controls

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 55
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