Cleared Traditional

K901512 - L SOPHIA

K901512 · Nishitomo Co., Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K901512

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 161d · This submission: 113d
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

All 23
Devices cleared under the same product code (LHD) and FDA review panel - the closest regulatory comparables to K901512.
MEDI-AID BASAL THERMOMETER
K952756 · Polymedica Industries, Inc. · Sep 1995
B-D DIGITAL THERMOMETER
K945427 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1995
BIOSELF 2000 FERTILITY INDICATOR
K904211 · Bioself, Inc. · Oct 1992
FERTILITY FORECASTER COMPUTER PROGRAM
K880618 · Fertile Time, Ltd. · Jun 1988
GENDER CHOICE INFORMATION KIT, FEMALE AND MALE
K870999 · Procare C/O Wiley, Rein & Fielding · Jul 1987
OVU-TRAC OVULATION TIMING KIT
K870528 · Ob/Gyn Concepts, Ltd. · May 1987
K901512 · L SOPHIA
Download PDF Nishitomo Co., Inc.