510(k) Report

510(k) · Cleared

Cleared

Sage Products Inc, Sharps Disposal Containers with Screw Top Caps

K980490510(k) TraditionalCleared Feb 24, 199815-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

Sage Products, Inc. · MMK Container, Sharps

Cleared on Feb 24, 1998 after a 15-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.

Decided
Feb 24, 1998
Review
15 days
Class
Class II
Product code
MMK
Recalls
None
Predicates
0

4 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2007: 2 descendants cleared2006: 1 descendant cleared1995200020052010201520202025
  1. This deviceK980490 Sage Products Inc, Sharps Disposal Containers with Screw Top CapsSage Products, Inc. · 1998
  2. Descendant · cites it directly · 0 of its ownK091690 Sharp ChuteHeathrow Scientific, LLC · 2009
  3. Descendant · cites it directly · 0 of its ownK071088 Life Latch Sharps & Biohazard ContainerM&M Industries, Inc. · 2007
  4. Descendant · cites it directly · 0 of its ownK063722 Sekurit Sharps Collection ContainerTechen Safety, Inc. · 2007
  5. Descendant · cites it directly · 0 of its ownK061933 Hager Miramatic Box Sharps Container and Cap Trap Needle RE-CapperHager Worldwide, Inc. · 2006

Most influential descendants

Showing 4 of 4 · See all
  • K091690Sharp ChuteHeathrow Scientific, LLC · 2009 · cites it directly0descendants
  • K071088Life Latch Sharps & Biohazard ContainerM&M Industries, Inc. · 2007 · cites it directly0descendants
  • K063722Sekurit Sharps Collection ContainerTechen Safety, Inc. · 2007 · cites it directly0descendants
  • K061933Hager Miramatic Box Sharps Container and Cap Trap Needle RE-CapperHager Worldwide, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980490Sage Products Inc, Sharps Disposal Containers with Screw Top CapsSage Products, Inc.1998—
+1K091690Sharp ChuteHeathrow Scientific, LLC2009—
+1K071088Life Latch Sharps & Biohazard ContainerM&M Industries, Inc.2007—
+1K063722Sekurit Sharps Collection ContainerTechen Safety, Inc.2007—
+1K061933Hager Miramatic Box Sharps Container and Cap Trap Needle RE-CapperHager Worldwide, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200910
FIG. 1 — Lineage of K980490, 1998–2009Source: 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
Get a 510(k) Report

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
*—Large Volume Sharps Container by Sage Products, Inc.
Named without a submission number
—
*—3 Quart Sharps Container by OnGard Systems, Inc.
Named without a submission number
—

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K091690Sharp ChuteHeathrow Scientific, LLC20090
K071088Life Latch Sharps & Biohazard ContainerM&M Industries, Inc.20070
K063722Sekurit Sharps Collection ContainerTechen Safety, Inc.20070
K061933Hager Miramatic Box Sharps Container and Cap Trap Needle RE-CapperHager Worldwide, Inc.20060

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?

  • Of its descendants, K091690 (Heathrow Scientific, LLC, 2009) has gone furthest, with 0 descendants 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.

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?

The Sage Sharps Disposal Containers with Screw Top Caps is intended for

single use disposal of used or contaminated medical sharps, including, but not

limited to, hypodermic needles, syringes, lancets, and Blood Needles. The

containers can be used in variety of healthcare settings. The containers are

suitable for physician offices, dental offices, laboratories, home health and

other generators of medical waste. The containers are also appropriate for

patient room applications.

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

Cite this page

510(k) Report. “K980490: Sage Products Inc, Sharps Disposal Containers with Screw Top Caps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980490

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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