Cleared Traditional

K172719 - HealthBeacon HB2 Sharps Bin

K172719 is an FDA 510(k) clearance for HealthBeacon HB2 Sharps Bin, manufactured by Healthbeacon, Ltd.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K172719 · Healthbeacon, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
245d
Days
Class 2
Risk

K172719 is an FDA 510(k) clearance for the HealthBeacon HB2 Sharps Bin. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Healthbeacon, Ltd. (Dublin, IE). The FDA issued a Cleared decision on May 11, 2018 after a review of 245 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Healthbeacon, Ltd. devices

FDA 510(k) Submission Details - K172719

510(k) Number K172719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2017
Decision Date May 11, 2018
Days to Decision 245 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 129d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMK Device Classification - Class 2, Special Controls

Product Code MMK Container, Sharps
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 General Hospital devices follow this clearance model.

Regulatory Peers - MMK Container, Sharps

All 41
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K172719.
OnSite Waste Sharps Container
K182235 · Bluestone Medical, Inc. · May 2019
Maxcon Two Gallon Chemotherapy Container
K180983 · Ningbo Maxcon Medical Technology Co., Ltd. · Jan 2019
Maxcon Sharps Container
K180984 · Ningbo Maxcon Medical Technology Co., Ltd. · Jan 2019
MEDLINE SHARPS CONTAINERS
K143693 · Medline Industries, Inc. · Nov 2015
MEDLINE SHARPS CONTAINER
K132767 · Medline Industries, Inc. · Feb 2014
BD RECYKLEEN SHARPS COLLECTORS
K112774 · Becton, Dickinson and Company · Mar 2012