Cleared Traditional

Powered Breast Pump (Models 7V and 7X) (K211016) - FDA 510(k) Clearance

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

K211016 · Haenim Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
450d
Days
Class 2
Risk

K211016 is an FDA 510(k) clearance for the Powered Breast Pump (Models 7V and 7X). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Haenim Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on June 29, 2022 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - 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: 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 Haenim Co., Ltd. devices

Submission Details

510(k) Number K211016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2021
Decision Date June 29, 2022
Days to Decision 450 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
290d slower than avg
Panel avg: 160d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

LK Consulting Group USA, Inc.
Priscilla Chung

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 127
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K211016.
Spectra Wearable
K220926 · Uzinmedicare Co., Ltd. · Dec 2022
Wearable breast pump
K221598 · Mayborn (Uk) Limited · Dec 2022
Ameda Pearl Electric Breast Pump
K221576 · Ameda, Inc. · Oct 2022
Wearable Breast Pump (Model S10)
K220309 · Shenzhen Lutejiacheng Technology Co., Ltd. · Jun 2022
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