510(k) Report

510(k) · Cleared

Cleared

Medline Sharps Containers

K143693510(k) TraditionalCleared Nov 6, 2015317-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

Medline Industries, Inc. · MMK Container, Sharps

Cleared on Nov 6, 2015 as substantially equivalent to K132767 (Medline Industries, Inc., 2014) after a 317-day review. Its family tree reaches back 1 generation to 2014. 6 later devices descend from it.

Decided
Nov 6, 2015
Review
317 days
Class
Class II
Product code
MMK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K132767 (2014). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2021: 2 descendants cleared2020: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant clearedK132767 · Medline Sharps Container · Medline Industries, Inc. · 20142010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 1 descendant K132767 · Medline Sharps Container · Medline Industries, Inc. · 20140
  1. Root · 1 generation backK132767 Medline Sharps ContainerMedline Industries, Inc. · 2014
  2. This deviceK143693 Medline Sharps ContainersMedline Industries, Inc. · 2015
  3. Descendant · cites it directly · 5 of its ownK190240 Tiger Sharps ContainersInternational Marketing Specialists, Inc. · 2019
  4. Descendant · 2 generations on · 2 of its ownK211464 Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021
  5. Descendant · 2 generations on · 1 of its ownK222905 Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon…Ningbo Maxcon Medical Technology Co., Ltd. · 2023
  6. Descendant · 3 generations on · 0 of its ownK253222 Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025
  7. Descendant · 2 generations on · 0 of its ownK211890 Promisemed Sharps containerPromisemed Hangzhou Meditech Co., Ltd. · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2019: 12020: 12021: 22023: 12025: 1
2019high 2 (2021) · low 0 (2022)2026

Most influential descendants

Showing 5 of 6 · See all
  • K190240Tiger Sharps ContainersInternational Marketing Specialists, Inc. · 2019 · cites it directly5descendants
  • K211464Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021 · 2 generations on2descendants
  • K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…Ningbo Maxcon Medical Technology Co., Ltd. · 2023 · 2 generations on1descendant
  • K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025 · 3 generations on0descendants
  • K211890Promisemed Sharps containerPromisemed Hangzhou Meditech Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K132767Medline Sharps ContainerMedline Industries, Inc.2014—
0 (this device)K143693Medline Sharps ContainersMedline Industries, Inc.2015—
+1K190240Tiger Sharps ContainersInternational Marketing Specialists, Inc.2019—
+2K211464Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd.2021—
+2K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps…Ningbo Maxcon Medical Technology Co., Ltd.2023—
+3K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd.2025—
+2K211890Promisemed Sharps containerPromisemed Hangzhou Meditech Co., Ltd.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202010
202120
202310
202510
FIG. 1 — Lineage of K143693, 2014–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

TypeNumberDeviceApplicantDecidedRecalls
*K132767Medline Sharps Container
Summary page 5
…n Name: Sharps Container Classification Name: Hypodermic single lumen needle (21 CRF 880.5570, product code – MMK, Class II) Predicate Device Medline Sharps Container, K132767 Comparison of Subject and Predicates Characteristic Proposed Device Predicate Device…
Medline Industries, Inc.2014—

Also cleared against K132767: 1 other device →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K190240Tiger Sharps ContainersInternational Marketing Specialists, Inc.20195

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?

  • Its one ancestor has no recall.
  • Of its descendants, K190240 (International Marketing Specialists, Inc., 2019) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K132767.

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

2007: 42008: 62009: 42010: 12011: 12012: 22013: 52014: 62015: 32016: 42017: 12018: 12019: 42020: 12021: 32022: 12023: 32025: 32026 (partial year): 2
2007high 6 (2008) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMK

84in 2025

2007: 63 days median2008: 61 days median2009: 100 days median2013: 136 days median2014: 210 days median2015: 115 days median2016: 258 days median2019: 265 days median2021: 149 days median2023: 251 days median2025: 84 days median
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

2007: 52008: 212009: 92010: 92011: 162012: 162013: 202014: 132015: 132016: 272017: 392018: 632019: 562020: 622021: 852022: 382023: 342024: 142025: 5
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200746305
2008661021
2009410009
20101—09
20111—016
20122—016
20135136020
20146210013
20153115013
20164258027
20171—039
20181—063
20194265056
20201—062
20213149085
20221—038
20233251034
20240—014
202538405
20262—0—

What is it indicated for?

Medline Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.

Indications for use as stated in the FDA summary.

Also cleared against K132767

1 other device cites the same predicate.

  • K172719HealthBeacon HB2 Sharps BinHealthbeacon, Ltd. · 2018

More from Medline Industries, Inc.

238 FDA decisions under this applicant name. See the company

  • DEN210049Medline ART Skin Harvesting SystemMedline Industries, Inc. · 2024
  • K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier…Medline Industries, Inc. · 2023
  • K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)Medline Industries, Inc. · 2023
  • K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc. · 2023
  • K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc. · 2022

Recent decisions in MMK

The MMK category page

  • K260845Huahong Sharps Container (HHR-I, HHR-II)Tianjin Huahong Technology Co., Ltd. · 2026
  • K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container…Taizhou Huangyan Guanhong Plastic Steel Products Factory · 2026
  • K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025
  • K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc. · 2025
  • K252637Community Containers (Flap and Daisy)Keter Canada, Inc. · 2025

https://510kreport.com/device/K143693 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143693: Medline Sharps Containers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143693

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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