510(k) Report

510(k) · Cleared

Cleared

Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421

K222906510(k) TraditionalCleared Jun 16, 2023266-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

Ningbo Maxcon Medical Technology Co., Ltd. · MMK Container, Sharps

Cleared on Jun 16, 2023 as substantially equivalent to K111085 (Rehrig Pacific Company, 2012) and 1 other predicate after a 266-day review. Its family tree reaches back 2 generations to 2012.

Decided
Jun 16, 2023
Review
266 days
Class
Class II
Product code
MMK
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K111085 (2012). No later device cites it as a predicate yet.

  1. Root · 2 generations backK111085 Sharps Tank Reusable Sharps ContainerRehrig Pacific Company · 2012
  2. 1 generation backK153274 Med-Tainer Single Deposit ContainerSnyder Industries, Inc. · 2016
  3. This deviceK222906 Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421Ningbo Maxcon Medical Technology Co., Ltd. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K111085Sharps Tank Reusable Sharps ContainerRehrig Pacific Company2012—
−1K153274Med-Tainer Single Deposit ContainerSnyder Industries, Inc.2016—
0 (this device)K222906Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421Ningbo Maxcon Medical Technology Co., Ltd.2023—
FIG. 1 — Lineage of K222906, 2012–2023Source: 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K111085Sharps Tank Reusable Sharps Container
Summary page 5
…ation Panel:General Hospital 6. Predicate Device Information:  Primary Predicate Device: Trade name:Sharps Tank Reusable Sharps Container The device (K111085), manufactured by Rehrig Pacific Company, located in 614 Hunters Lane, Brentwood, Tennessee 37027, USA. Common name:Sha…
Rehrig Pacific Company2012—
*K153274Med-Tainer Single Deposit Container
Summary page 5
…880.5570-Class II Classification Panel: General Hospital  Second Predicate Device: Trade name:Med-Tainer Single Deposit Container (SDC) The device ( K153274 ) manufactured by Snyder Industries, Inc., located in 6940 O Street, Suite 100,Lincoln, NE 68510, USA. Common name:Shar…
Snyder Industries, Inc.2016—

Also cleared against K111085: 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 11 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K111085.

How does its category compare?

All MMK devices

MMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?

Maxcon Reusable Sharps Container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K222906: Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222906

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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