Cleared Traditional

SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM (K112644) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K112644 · Lotus Bio, Ltd. · Obstetrics & Gynecology device
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Dec 2012
Decision
464d
Days
Class 2
Risk

K112644 is an FDA 510(k) clearance for the SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Lotus Bio, Ltd. (Pawtucket, US). The FDA issued a Cleared decision on December 19, 2012 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - the FDA obstetrics and gynecology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Lotus Bio, Ltd. devices

Submission Details

510(k) Number K112644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2011
Decision Date December 19, 2012
Days to Decision 464 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
304d slower than avg
Panel avg: 160d · This submission: 464d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

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All 49
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