Cleared Traditional

HealthBeacon HB2 Sharps Bin (K172719) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172719 · Healthbeacon, Ltd. · General Hospital
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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

Submission Details

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.

Device Classification

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 20
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