510(k) Report

510(k) · Cleared

Cleared

Sharps Container

K132476510(k) TraditionalCleared May 2, 2014267-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

Grp & Associates · MMK Container, Sharps

Cleared on May 2, 2014 as substantially equivalent to K112774 (Becton, Dickinson and Company, 2012) after a 267-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.

Decided
May 2, 2014
Review
267 days
Class
Class II
Product code
MMK
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K943134 (1994). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2025: 1 descendant clearedK943134 · B-D Guardian Nestable Sharps Collectors · Med-Safe Systems, Inc. · 1994K112774 · BD Recykleen Sharps Collectors · Becton, Dickinson and Company · 20121990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K112774 · BD Recykleen Sharps Collectors · Becton, Dickinson and Company · 2012K943134 · B-D Guardian Nestable Sharps Collectors · Med-Safe Systems, Inc. · 19940
  1. Root · 2 generations backK943134 B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc. · 1994
  2. 1 generation backK112774 BD Recykleen Sharps CollectorsBecton, Dickinson and Company · 2012
  3. This deviceK132476 Sharps ContainerGrp & Associates · 2014
  4. Descendant · cites it directly · 1 of its ownK151249 Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2…Pureway Compliance, Inc. · 2015
  5. Descendant · 2 generations on · 0 of its ownK251874 PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc. · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K151249Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps…Pureway Compliance, Inc. · 2015 · cites it directly1descendant
  • K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K943134B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc.1994—
−1K112774BD Recykleen Sharps CollectorsBecton, Dickinson and Company2012—
0 (this device)K132476Sharps ContainerGrp & Associates2014—
+1K151249Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon…Pureway Compliance, Inc.2015—
+2K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
202510
FIG. 1 — Lineage of K132476, 1994–2025Source: 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
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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
*K112774BD Recykleen Sharps Collectors
Summary page 1
…0.5570 Product Code: MMK Device Class: Class 11 Classification Panel: General Hospital 5. Predicate Devices K112774 - BD Recylleen Sharps Collector Page5-i GRP and Associates Trad…
Becton, Dickinson and Company2012—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K151249Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps…Pureway Compliance, Inc.20151

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 20 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K151249 (Pureway Compliance, Inc., 2015) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MMK devices

MMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?

GRP' Sharps Container: GRP l.5QT: (1.5 qt capacity) The empty device, as it sits, is a red container that measures 4"X4"X7.5" and weighs 6oz. The opening/closure measures 2.5' in diameter. The intended use of the vertical entry,single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. Thecontainer is intended to be used in hospitals, clinics, operating rooms…

Read the full statement (364 words)

GRP' Sharps Container: GRP l.5QT: (1.5 qt capacity) The empty device, as it sits, is a red container that measures 4"X4"X7.5" and weighs 6oz. The opening/closure measures 2.5' in diameter. The intended use of the vertical entry,single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. Thecontainer is intended to be used in hospitals, 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.

GRP' Sharps Container GRP I10: The empty device, as it sits, is a red container that measures 9.75"X6"X9.75" and weighs l6oz. The opening/closure measures 2.5' in diameter. The intended use of the vertical entry,single use, sharps containers, is to provide a receptacle for used, contaminated medical shamps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, 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.

GRP Sharps Container GRP 20: The empty device, as it sits, is a red container that measures 9.75"X6"X 13.75" and weighs I lb 9oz. The opening/closure measures 2.5" in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical shamps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, 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.

GRP Sharps Container GRP 30: The empty device, as it sits, is a red container that measures 9.75"X6"X 18.75" and weighs 2lbs. The opening/closure measures 2.5" in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical shamps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, 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. “K132476: Sharps Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132476

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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