Cleared Traditional

K212955 - Fit Pro Breast Pump

K212955 is an FDA 510(k) clearance for Fit Pro Breast Pump, manufactured by Hygeia II Medical Group, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K212955 · Hygeia II Medical Group, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
180d
Days
Class 2
Risk

K212955 is an FDA 510(k) clearance for the Fit Pro Breast Pump. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Hygeia II Medical Group, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 15, 2022 after a review of 180 days - an extended review 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: 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 Hygeia II Medical Group, Inc. devices

FDA 510(k) Submission Details - K212955

510(k) Number K212955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2021
Decision Date March 15, 2022
Days to Decision 180 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
20d slower than avg
Panel avg: 160d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - HGX Pump, Breast, Powered

All 136
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K212955.
Wearable Breast Pump (Model S9)
K220596 · Shenzhen TPH Technology Co., Ltd. · May 2022
Electric Breast Pump
K212564 · Guangdong Horigen Mother & Baby Products Co., Ltd. · May 2022
ARDO Alyssa
K212773 · Ardo Medical AG · Apr 2022
Electric Breast Pump
K211024 · Shantou Huihengqi Electronic Technology Co., Ltd. · Feb 2022
Wearable Breast Pump (Model S12)
K212180 · Shenzhen TPH Technology Co., Ltd. · Feb 2022
Lucy Breast Pump
K213311 · Willow Innovations, Inc. · Feb 2022