Cleared Traditional

K201213 - Pasteur Pipette 3mL

K201213 is the FDA 510(k) clearance for Pasteur Pipette 3mL by Hertart Aps. It is a Class 2 Obstetrics & Gynecology device (product code MQK) cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K201213 · Hertart Aps · Obstetrics & Gynecology device
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Dec 2020
Decision
225d
Days
Class 2
Risk

K201213 is an FDA 510(k) clearance for the Pasteur Pipette 3mL, Pasteur Pipette 1mL. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Hertart Aps (Västra Frölunda, SE). The FDA issued a Cleared decision on December 16, 2020 after a review of 225 days - an extended review cycle.

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: 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 Hertart Aps devices

Submission Details

510(k) Number K201213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2020
Decision Date December 16, 2020
Days to Decision 225 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
65d slower than avg
Panel avg: 160d · This submission: 225d
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.

Regulatory Peers - MQK Labware, Assisted Reproduction

All 18
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