Cleared Traditional

K233440 - Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)

K233440 is an FDA 510(k) clearance for Avalon CL Fetal & Maternal (F&M) Pod (8..., manufactured by Philips Medizin Systeme Boeblingen GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K233440 · Philips Medizin Systeme Boeblingen GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
258d
Days
Class 2
Risk

K233440 is an FDA 510(k) clearance for the Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&.... Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on July 2, 2024 after a review of 258 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - 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 Philips Medizin Systeme Boeblingen GmbH devices

FDA 510(k) Submission Details - K233440

510(k) Number K233440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2023
Decision Date July 02, 2024
Days to Decision 258 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
98d slower than avg
Panel avg: 160d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
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 - HGM System, Monitoring, Perinatal

All 155
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K233440.
Fetal & Maternal Monitor (F15A, F15A Air)
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Sonicaid Team3
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Novii+ Wireless Patch System
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Bloomlife MFM-Pro
K222327 · Bloom Technologies NV · Feb 2023
Mural Perinatal Surveillance
K220732 · Ge Medical Systems Information Technologies, Inc. · Jun 2022