Cleared Traditional

L SOPHIA (K901512) - FDA 510(k) Clearance

K901512 · Nishitomo Co., Inc. · Obstetrics & Gynecology device
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Jul 1990
Decision
113d
Days
-
Risk

K901512 is an FDA 510(k) clearance for the L SOPHIA. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Nishitomo Co., Inc. (Japan, JP). The FDA issued a Cleared decision on July 20, 1990 after a review of 113 days - within the typical 510(k) review window.

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.

View all Nishitomo Co., Inc. devices

Submission Details

510(k) Number K901512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1990
Decision Date July 20, 1990
Days to Decision 113 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 160d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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