510(k) Report

510(k) · Cleared

Cleared

Sharps Away Disposable Container

K072667510(k) TraditionalCleared Oct 10, 200719-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

Solutions, Inc. · MMK Container, Sharps

Cleared on Oct 10, 2007 as substantially equivalent to K943575 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) after a 19-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.

Decided
Oct 10, 2007
Review
19 days
Class
Class II
Product code
MMK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K943575 (1994). 4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant clearedK943575 · B-D Guardian Nestable Sharps Collectors · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19941990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 1 descendant K943575 · B-D Guardian Nestable Sharps Collectors · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19940
  1. Root · 1 generation backK943575 B-D Guardian Nestable Sharps CollectorsBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
  2. This deviceK072667 Sharps Away Disposable ContainerSolutions, Inc. · 2007
  3. Descendant · cites it directly · 1 of its ownK091736 Sharpsmart Disposable Sharps Container, Model S2Daniels Corporation Pty, Inc. · 2009
  4. Descendant · 2 generations on · 0 of its ownK132792 Ecoship Disposable Sharps Container, Ecoship Disposable Sharps…Daniels Sharpsmart, Inc. · 2014
  5. Descendant · cites it directly · 0 of its ownK133031 Sharpsology 2Industrial Water Solutions, Inc. · 2013
  6. Descendant · cites it directly · 0 of its ownK101567 Sharps ContainerCixi Leinuo Plastic Co., Ltd. · 2010

Most influential descendants

Showing 4 of 4 · See all
  • K091736Sharpsmart Disposable Sharps Container, Model S2Daniels Corporation Pty, Inc. · 2009 · cites it directly1descendant
  • K132792Ecoship Disposable Sharps Container, Ecoship Disposable Sharps ContainerDaniels Sharpsmart, Inc. · 2014 · 2 generations on0descendants
  • K133031Sharpsology 2Industrial Water Solutions, Inc. · 2013 · cites it directly0descendants
  • K101567Sharps ContainerCixi Leinuo Plastic Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K943575B-D Guardian Nestable Sharps CollectorsBd Becton Dickinson Vacutainer Systems Preanalytic1994—
0 (this device)K072667Sharps Away Disposable ContainerSolutions, Inc.2007—
+1K091736Sharpsmart Disposable Sharps Container, Model S2Daniels Corporation Pty, Inc.2009—
+2K132792Ecoship Disposable Sharps Container, Ecoship Disposable Sharps ContainerDaniels Sharpsmart, Inc.2014—
+1K133031Sharpsology 2Industrial Water Solutions, Inc.2013—
+1K101567Sharps ContainerCixi Leinuo Plastic Co., Ltd.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201310
201410
FIG. 1 — Lineage of K072667, 1994–2014Source: 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? (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
*K943575B-D Guardian Nestable Sharps Collectors
Summary page 1
…vice: Company Product 510(k)# Becton Dickinson B-D Guardian Nestable Sharps Collectors K943575 Description: Sharps Away Disposable Containers are injection molded polypropylene plastic. The containers are closable, puncture…
Bd Becton Dickinson Vacutainer Systems Preanalytic1994—

Also cleared against K943575: 4 other devices →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091736Sharpsmart Disposable Sharps Container, Model S2Daniels Corporation Pty, Inc.20091
K133031Sharpsology 2Industrial Water Solutions, Inc.20130
K101567Sharps ContainerCixi Leinuo Plastic Co., Ltd.20100

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, K091736 (Daniels Corporation Pty, Inc., 2009) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K943575.

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

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?

Sharps Away Disposable Containers and accessories 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.

There are fourteen (14) containers and four (4) holders included in this submission. The model number, size, color and syringe size specification of each container and holder are as follows: (See attached sheet.)

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072667: Sharps Away Disposable Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072667

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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