510(k) · Cleared

Cleared

Sekurit Sharps Collection Container

K063722510(k) TraditionalCleared Mar 5, 200780-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

Techen Safety, Inc. · MMK Container, Sharps

Cleared on Mar 5, 2007 as substantially equivalent to K943139 (Med-Safe Systems, Inc., 1994) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1994.

Decided: Mar 5, 2007
Review: 80 days
Class: Class II
Product code: MMK
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K943139 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK943139 B-D Guardian One Piece Sharps CollectorsMed-Safe Systems, Inc. · 1994
This deviceK063722 Sekurit Sharps Collection ContainerTechen Safety, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943139	B-D Guardian One Piece Sharps Collectors	Med-Safe Systems, Inc.	1994	—
0 (this device)	K063722	Sekurit Sharps Collection Container	Techen Safety, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K063722, 1994–2007Source: 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
*	K943139	B-D Guardian One Piece Sharps Collectors Summary page 1 …ass II, MMK and 21 CFR 880.5570 Classification Panel: General Hospital 1)B-D@ Guardian One Piece Sharps Collectors, K943139 Predicate Device Name and 510(k) 2) Sage Products, Sharps Disposal Containers with Screw Number:…	Med-Safe Systems, Inc.	1994	—
*	K980490	Sage Products Inc, Sharps Disposal Containers with Screw Top Caps Summary page 1 …Sharps Collectors, K943139 Predicate Device Name and 510(k) 2) Sage Products, Sharps Disposal Containers with Screw Number: Top Caps, K980490 Device Description: The Sekurit Sharps Collection Container is a single piece container which is blow molded of High Density…	Sage Products, Inc.	1998	—

Also cleared against K943139: 1 other device →

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?

None of the 2 ancestors has a recall.
1 other device also cites its predicate K943139.

How does its category compare?

All MMK devices

MMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

Techen Safety Sharps Disposal Containers with Screw Top Caps are intended for single use disposal of used or contaminated medical sharps, including but not limited to, hypodermic needles, syringes, lancets, and Blood Needles. The containers can be used in a variety of healthcare settings. They are suitable for physicians offices, dental offices, laboratories, home health, patient room, and other generation of medical waste.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063722 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063722: Sekurit Sharps Collection Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063722

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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