510(k) · Cleared

Cleared

MedSource Sharps Dart

K150333510(k) TraditionalCleared May 8, 201587-day reviewClass II21 CFR 880.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medsource International, LLC · MMK Container, Sharps

Cleared on May 8, 2015 as substantially equivalent to K972279 (Sage Products, Inc., 1997) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1994.

Decided: May 8, 2015
Review: 87 days
Class: Class II
Product code: MMK
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K943134 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK943134 B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc. · 1994
1 generation backK140285 B Travelsavvy Sharps ContainerBellegrove Medical Supply, Inc. · 2014
This deviceK150333 MedSource Sharps DartMedsource International, LLC · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K943134	B-D Guardian Nestable Sharps Collectors	Med-Safe Systems, Inc.	1994	—
−1	K140285	B Travelsavvy Sharps Container	Bellegrove Medical Supply, Inc.	2014	—
0 (this device)	K150333	MedSource Sharps Dart	Medsource International, LLC	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K150333, 1994–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MMK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MMK device

#1 K253773 Guanhong Sharps Container (GHW-1F1); Guanhong…score 12.3 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K972279	Sharps Shuttle Summary page 4 …/Sharps Shuttle with Container Locking Mechanism* 510(K) K150333 K972279 K140285 Regulatory Name Hypodermic Single- Hypodermic Single- Hypodermic Single-…	Sage Products, Inc.	1997	—
*	K140285	B Travelsavvy Sharps Container Summary page 4 …le with Container Locking Mechanism* 510(K) K150333 K972279 K140285 Regulatory Name Hypodermic Single- Hypodermic Single- Hypodermic Single- Lumen Need…	Bellegrove Medical Supply, Inc.	2014	—

Also cleared against K972279: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 20.1 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K972279.

How does its category compare?

All MMK devices

MMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · MMK

3in 2025

2007high 6 (2008) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMK

84in 2025

2007high 265 (2019) · low 61 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MMK

No recall names MMK since 2007.

Adverse event reports per year · MMK

5in 2025

2007high 85 (2021) · low 5 (2007)2025

MAUDE reports naming product code MMK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	4	63	5
2008	6	61	21
2009	4	100	9
2010	1	—	9
2011	1	—	16
2012	2	—	16
2013	5	136	20
2014	6	210	13
2015	3	115	13
2016	4	258	27
2017	1	—	39
2018	1	—	63
2019	4	265	56
2020	1	—	62
2021	3	149	85
2022	1	—	38
2023	3	251	34
2024	0	—	14
2025	3	84	5
2026	2	—	—

What is it indicated for?

The MedSource Sharps Dart is a non-sterile single-use disposable sharps container with a permanent closure system for a contaminated 1 ml or smaller syringe. Its intended use is by health care professionals in a setting where standard sharps containers are not accessible such as EMS, home healthcare, and laboratories. Its permanent closure system protects the user prior to disposal by incineration or decontamination by autoclave.

MedSource Sharps Dart Model No. MS-64250

Color-Clear/translucent with red closure

Length-17cm (6.7 in.)

Diameter-3cm (1.2 in.)

Empty Weight- 255 gm ( 0.9 oz)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150333 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150333: MedSource Sharps Dart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150333

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026