Cleared Traditional

K173699 - The Pump by Babyation

K173699 is an FDA 510(k) clearance for The Pump by Babyation, manufactured by Babyation, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K173699 · Babyation, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
121d
Days
Class 2
Risk

K173699 is an FDA 510(k) clearance for the The Pump by Babyation. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Babyation, LLC (St. Louis, US). The FDA issued a Cleared decision on April 4, 2018 after a review of 121 days - within the typical 510(k) review window.

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 Babyation, LLC devices

FDA 510(k) Submission Details - K173699

510(k) Number K173699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2017
Decision Date April 04, 2018
Days to Decision 121 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
39d faster than avg
Panel avg: 160d · This submission: 121d
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 Consultant

Acknowledge Regulatory Strategies, LLC
Allison Komiyama

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 143
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K173699.
Elvie Pump
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Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
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