Cleared Traditional

K021978 - PETIT SOPHIA

K021978 · Nishitomo Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
295d
Days
-
Risk

K021978 is an FDA 510(k) clearance for the PETIT SOPHIA. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Nishitomo Co., Inc. (Gray, US). The FDA issued a Cleared decision on April 8, 2003 after a review of 295 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel. 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K021978

510(k) Number K021978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2002
Decision Date April 08, 2003
Days to Decision 295 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 161d · This submission: 295d
Pathway characteristics
Predicate-based equivalence.

LHD Device Classification - Class 0,

Product Code LHD Device, Fertility Diagnostic, Proceptive
Device Class -

Regulatory Peers - LHD Device, Fertility Diagnostic, Proceptive

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K021978 · PETIT SOPHIA
Download PDF FDA Summary Nishitomo Co., Inc.