Cleared Traditional

K121322 - CLOSER TO NATURE

K121322 is an FDA 510(k) clearance for CLOSER TO NATURE, manufactured by Mayborn Group Limited. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K121322 · Mayborn Group Limited · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
29d
Days
Class 2
Risk

K121322 is an FDA 510(k) clearance for the CLOSER TO NATURE. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Mayborn Group Limited (Northumberlan, GB). The FDA issued a Cleared decision on May 31, 2012 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K121322

510(k) Number K121322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2012
Decision Date May 31, 2012
Days to Decision 29 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 161d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HGX Device Classification - Class 2, Special Controls

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
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 Consultant

Regulatory Technology Services, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGX Pump, Breast, Powered

All 238
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K121322.
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
K121478 · Mapa GmbH · Apr 2013
LANSINOH POWERED ELECTRIC BREAST PUMP
K122474 · Lansinoh Laboratories Saglik Gerecleri Tasarim San · Dec 2012
RUMBLE TUFF
K113315 · Acute Ideas Co. , Ltd. · Nov 2012
LUCINA-MELODI
K112856 · Genadyne Biotechnologies, Inc. · May 2012
CLOSER TO NATURE ELECTRIC BREAST PUMP
K113664 · Mayborn Group Limited · Feb 2012
FREEMIE (R)
K111411 · Dao Health · Feb 2012

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K121322 · CLOSER TO NATURE
Download PDF FDA Summary Mayborn Group Limited