510(k) Report

510(k) · Cleared

Cleared

Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong

K253773510(k) TraditionalCleared May 22, 2026177-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

Taizhou Huangyan Guanhong Plastic Steel Products Factory · MMK Container, Sharps

Cleared on May 22, 2026 as substantially equivalent to K180984 (Ningbo Maxcon Medical Technology Co., Ltd., 2019) after a 177-day review. Its family tree reaches back 4 generations to 1994.

Decided
May 22, 2026
Review
177 days
Class
Class II
Product code
MMK
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K943575 (1994). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestorsReference device: K222905 · Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) · Ningbo Maxcon Medical Technology Co., Ltd. · 2023Reference device: K201523 · Sharps container · Zhejiang Gongdong Medical Technology Co., Ltd. · 2020K943575 · B-D Guardian Nestable Sharps Collectors · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1994K130281 · Oak Ridge Products Sharp Container · Oak Ridge Products, LLC · 2013K161180 · Oak Ridge Products Sharps Containers · Oak Ridge Products, LLC · 2016K180984 · Maxcon Sharps Container · Ningbo Maxcon Medical Technology Co., Ltd. · 20191990200020102020
Other ancestors, by generation 4 generations back: 2 other ancestors K180984 · Maxcon Sharps Container · Ningbo Maxcon Medical Technology Co., Ltd. · 2019K161180 · Oak Ridge Products Sharps Containers · Oak Ridge Products, LLC · 2016K130281 · Oak Ridge Products Sharp Container · Oak Ridge Products, LLC · 2013K943575 · B-D Guardian Nestable Sharps Collectors · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19940
  1. Root · 4 generations backK943575 B-D Guardian Nestable Sharps CollectorsBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
  2. 3 generations backK130281 Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 2013
  3. 2 generations backK161180 Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016
  4. 1 generation backK180984 Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019
  5. This deviceK253773 Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container…Taizhou Huangyan Guanhong Plastic Steel Products Factory · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K943575B-D Guardian Nestable Sharps CollectorsBd Becton Dickinson Vacutainer Systems Preanalytic1994—
−3K130281Oak Ridge Products Sharp ContainerOak Ridge Products, LLC2013—
−2K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC2016—
−1K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd.2019—
0 (this device)K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4)…Taizhou Huangyan Guanhong Plastic Steel Products Factory2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
FIG. 1 — Lineage of K253773, 1994–2026Source: 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 K253222 Gongdong Sharps Container (SCR-01Q, SCR-01G…score 11.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K180984Maxcon Sharps Container
Summary page 6
…s Container Regulation Description: Hypodermic single lumen needle. Product Code: MMK Regulation Number: CFR880.5570 Device Class: II The device 510k number is K180984, manufactured by Ningbo Maxcon Medical Technology Co., Ltd, located in No.228,Dongxin Road, Dongqiao Town, Ningbo, Zhejiang Pro…
Ningbo Maxcon Medical Technology Co., Ltd.2019—
†K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…Ningbo Maxcon Medical Technology Co., Ltd.2023—
†K201523Sharps containerZhejiang Gongdong Medical Technology Co., Ltd.2020—

Also cleared against K180984: 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?

  • The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
  • None of the 6 ancestors has a recall.
  • 1 other device also cites its predicate K180984.

How does its category compare?

All MMK devices

MMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?

Guanhong Sharps containers are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.

Indications for use as stated in the FDA summary.

Also cleared against K180984

1 other device cites the same predicate.

  • K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025

Recent decisions in MMK

The MMK category page

  • K260845Huahong Sharps Container (HHR-I, HHR-II)Tianjin Huahong Technology Co., Ltd. · 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
  • K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc. · 2023

https://510kreport.com/device/K253773 · printed Nov 5, 2026

Cite this page

510(k) Report. “K253773: Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253773

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026