510(k) Report

510(k) · Cleared

Cleared

B Travelsavvy Sharps Container

K140285510(k) TraditionalCleared Dec 4, 2014303-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

Bellegrove Medical Supply, Inc. · MMK Container, Sharps

Cleared on Dec 4, 2014 as substantially equivalent to K943134 (Med-Safe Systems, Inc., 1994) after a 303-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided
Dec 4, 2014
Review
303 days
Class
Class II
Product code
MMK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K943134 (1994). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant clearedK943134 · B-D Guardian Nestable Sharps Collectors · Med-Safe Systems, Inc. · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant K943134 · B-D Guardian Nestable Sharps Collectors · Med-Safe Systems, Inc. · 19940
  1. Root · 1 generation backK943134 B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc. · 1994
  2. This deviceK140285 B Travelsavvy Sharps ContainerBellegrove Medical Supply, Inc. · 2014
  3. Descendant · cites it directly · 0 of its ownK150333 MedSource Sharps DartMedsource International, LLC · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K150333MedSource Sharps DartMedsource International, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K943134B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc.1994—
0 (this device)K140285B Travelsavvy Sharps ContainerBellegrove Medical Supply, Inc.2014—
+1K150333MedSource Sharps DartMedsource International, LLC2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K140285, 1994–2015Source: 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
*K943134B-D Guardian Nestable Sharps Collectors
Summary page 4
…marketed device: Trade Name: BD Guardian™ Sharps Container Common Name: Sharps Container Classification: 21CFR 880.5570 —Class |l Product Code: MMK Predicate 510k No K943134 Cleared 11/07/1994 CFR Reference: 21CFR 880.5570 —Class Il Classification Panel: General Hospital 5. Device Description The B T…
Med-Safe Systems, Inc.1994—

Also cleared against K943134: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K150333MedSource Sharps DartMedsource International, LLC20150

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, K150333 (Medsource International, LLC, 2015) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K943134.

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?

The Travel Savvy Sharps Container is a single-use device intended for disposal of sharps waste by a single user in a private site of use. When mounted with the appropriate bracket, the Travel Savvy Sharps Container can be used for sharps disposal in vehicles.

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. “K140285: B Travelsavvy Sharps Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140285

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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