510(k) Report

510(k) · Cleared

Cleared

Oak Ridge Products Sharp Container

K130281510(k) AbbreviatedCleared Jun 21, 2013136-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

Oak Ridge Products, LLC · MMK Container, Sharps

Cleared on Jun 21, 2013 as substantially equivalent to K943575 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) and 2 other predicates after a 136-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.

Decided
Jun 21, 2013
Review
136 days
Class
Class II
Product code
MMK
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K943575 (1994). 3 ancestors in all. 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 2 other ancestors2014: 2 descendants cleared2016: 1 descendant cleared2023: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK943575 · B-D Guardian Nestable Sharps Collectors · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants 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 deviceK130281 Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 2013
  3. Descendant · cites it directly · 3 of its ownK161180 Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016
  4. Descendant · 2 generations on · 2 of its ownK180984 Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019
  5. Descendant · 3 generations on · 0 of its ownK253773 Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container…Taizhou Huangyan Guanhong Plastic Steel Products Factory · 2026
  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 · cites it directly · 0 of its ownK231484 PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc. · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2014: 22016: 12019: 12023: 12025: 12026: 1
2014high 2 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all
  • K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016 · cites it directly3descendants
  • K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019 · 2 generations on2descendants
  • K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong…Taizhou Huangyan Guanhong Plastic Steel Products Factory · 2026 · 3 generations on0descendants
  • K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025 · 3 generations on0descendants
  • K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc. · 2023 · 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)K130281Oak Ridge Products Sharp ContainerOak Ridge Products, LLC2013—
+1K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC2016—
+2K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd.2019—
+3K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4)…Taizhou Huangyan Guanhong Plastic Steel Products Factory2026—
+3K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd.2025—
+1K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201610
201910
202310
202510
202610
FIG. 1 — Lineage of K130281, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (3)

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 2
…lassification Panel: needles ' 21 CFR 880.5570 — Class Il General Hospital Legally Marketed Equivalent Devices: Company Product 510(k)# Becton Dickinson B-D Guardian™ K943575 Nestable Sharps Collectors Covidien (originally cleared | Multi-purpose Sharps K943659 under Sage Products now | Container owned…
Bd Becton Dickinson Vacutainer Systems Preanalytic1994—
*K943659Ancillary and Large Volume Sharps Disposal Containers
Summary page 2
…rketed Equivalent Devices: Company Product 510(k)# Becton Dickinson B-D Guardian™ K943575 Nestable Sharps Collectors Covidien (originally cleared | Multi-purpose Sharps K943659 under Sage Products now | Container owned by Covidien) Covidien (originally cleared | SharpSafety™ K943660 under Sage Products n…
Sage Products, Inc.1995—
*K943660Phlebotomy Sharps Disposal Containers
Summary page 2
…ollectors Covidien (originally cleared | Multi-purpose Sharps K943659 under Sage Products now | Container owned by Covidien) Covidien (originally cleared | SharpSafety™ K943660 under Sage Products now | Phlebotomy Containers owned by Covidien) 5. Product Description: The Oak Ridge Products Sharps Contai…
Sage Products, Inc.1995—

Also cleared against K943575: 4 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC20163
K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc.20230
K141759Oak Ridge Products Multi-Purpose Sharps ContainersOak Ridge Products, LLC20140
K132792Ecoship Disposable Sharps Container, Ecoship Disposable Sharps ContainerDaniels Sharpsmart, Inc.20140

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K161180 (Oak Ridge Products, LLC, 2016) has gone furthest, with 3 descendants 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. 2013, 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?

Oak Ridge Products Sharps containers are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals.

The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device. The 5.4 quart is intended to be used with an appropriate mounting device.

The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K943575

4 other devices cite the same predicate.

  • K131708Bwcsh-1 Sharps ContainerBradford Wright Companies, Inc. · 2014
  • K072667Sharps Away Disposable ContainerSolutions, Inc. · 2007
  • K980003M500-100 Sharps ContainerImagination Medical, Inc. · 1998
  • K963830Sharps Container Model# SC001Image Medical, Inc. · 1997

More from Oak Ridge Products, LLC

3 FDA decisions under this applicant name. See the company

  • K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016
  • K141759Oak Ridge Products Multi-Purpose Sharps ContainersOak Ridge Products, LLC · 2014

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/K130281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130281: Oak Ridge Products Sharp Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130281

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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