Cleared Traditional

K121566 - PLANER BT37 INCUBATOR

K121566 is an FDA 510(k) clearance for PLANER BT37 INCUBATOR, manufactured by Planer Plc. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K121566 · Planer Plc · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
184d
Days
Class 2
Risk

K121566 is an FDA 510(k) clearance for the PLANER BT37 INCUBATOR. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Planer Plc (Poway, US). The FDA issued a Cleared decision on November 29, 2012 after a review of 184 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - 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.

FDA 510(k) Submission Details - K121566

510(k) Number K121566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2012
Decision Date November 29, 2012
Days to Decision 184 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
23d slower than avg
Panel avg: 161d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQG Device Classification - Class 2, Special Controls

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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 - MQG Accessory, Assisted Reproduction

All 46
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K121566.
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