510(k) · Cleared

Cleared

Sharps Container

K101567510(k) TraditionalCleared Sep 2, 201090-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

Cixi Leinuo Plastic Co., Ltd. · MMK Container, Sharps

Cleared on Sep 2, 2010 as substantially equivalent to K072667 (Solutions, Inc., 2007) after a 90-day review. Its family tree reaches back 2 generations to 1994.

Decided: Sep 2, 2010
Review: 90 days
Class: Class II
Product code: MMK
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K943575 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK943575 B-D Guardian Nestable Sharps CollectorsBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
1 generation backK072667 Sharps Away Disposable ContainerSolutions, Inc. · 2007
This deviceK101567 Sharps ContainerCixi Leinuo Plastic Co., Ltd. · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K943575	B-D Guardian Nestable Sharps Collectors	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	—
−1	K072667	Sharps Away Disposable Container	Solutions, Inc.	2007	—
0 (this device)	K101567	Sharps Container	Cixi Leinuo Plastic Co., Ltd.	2010	—

FIG. 1 — Lineage of K101567, 1994–2010Source: 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K072667	Sharps Away Disposable Container Summary page 1 …sification Name :Container, Sharps Predicate Devices: Model Manufacturer K Number Submitted Device Sharps Away Solutions, Inc. K072667 Ln-T1 DisposableLn Containers 3. Classifications Names & Citations: 21CFR 884.6120, MMK, Sharps Container…	Solutions, Inc.	2007	—

Also cleared against K072667: 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 16 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K072667.

How does its category compare?

All MMK devices

MMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 sharps container are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101567 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101567: Sharps Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101567

Report an extraction error

Are you the manufacturer?

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