510(k) · Cleared

Cleared

Sharp Chute

K091690510(k) TraditionalCleared Jul 28, 200948-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

Heathrow Scientific, LLC · MMK Container, Sharps

Cleared on Jul 28, 2009 as substantially equivalent to K943139 (Med-Safe Systems, Inc., 1994) and 3 other predicates after a 48-day review. Its family tree reaches back 3 generations to 1994.

Decided: Jul 28, 2009
Review: 48 days
Class: Class II
Product code: MMK
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K943892 (1994). 7 ancestors in all, the oldest K943139 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK943892 Point of Use Sharps a GatorDevon Industries, Inc. · 1994
2 generations backK955514 Sharps Safe 1.5 & Sharps Safe 2.0Dura-Vac Products · 1996
1 generation backK990936 The VaultStik Stoppers, Inc. · 1999
This deviceK091690 Sharp ChuteHeathrow Scientific, LLC · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K943892	Point of Use Sharps a Gator	Devon Industries, Inc.	1994	—
−2	K955514	Sharps Safe 1.5 & Sharps Safe 2.0	Dura-Vac Products	1996	—
−1	K990936	The Vault	Stik Stoppers, Inc.	1999	—
0 (this device)	K091690	Sharp Chute	Heathrow Scientific, LLC	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1997	2	0
1998	1	0

FIG. 1 — Lineage of K091690, 1994–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K253773 Guanhong Sharps Container (GHW-1F1); Guanhong…score 12.3 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K943139	B-D Guardian One Piece Sharps Collectors Summary page 1 …Predicates: Predicate devices to which Sharp Chute TM is substantially equivalent: o K943139 - B-D, Guardian One Piece-Sharps Collectors o K990936 - Stik Stoppers, The Vault…	Med-Safe Systems, Inc.	1994	—
*	K990936	The Vault Summary page 1 …equivalent: o K943139 - B-D, Guardian One Piece-Sharps Collectors o K990936 - Stik Stoppers, The Vault o K980490 - Sage Products, Sharps Containers with…	Stik Stoppers, Inc.	1999	—
*	K980490	Sage Products Inc, Sharps Disposal Containers with Screw Top Caps Summary page 1 …o K943139 - B-D, Guardian One Piece-Sharps Collectors o K990936 - Stik Stoppers, The Vault o K980490 - Sage Products, Sharps Containers with Screw Top Caps…	Sage Products, Inc.	1998	—
*	K964387	Point of Use II Sharps-a-Gator Summary page 1 …o K980490 - Sage Products, Sharps Containers with Screw Top Caps o K964387 - Graphic Controls, Point of use II Sharps- A-Gator Device Description: * The Sha…	Graphic Controls Corp.	1997	—

Also cleared against K943139: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
None of the 7 ancestors has a recall.
1 other device also cites its predicate K943139.

How does its category compare?

All MMK devices

MMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MMK

3in 2025

2007high 6 (2008) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMK

84in 2025

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	4	63	5
2008	6	61	21
2009	4	100	9
2010	1	—	9
2011	1	—	16
2012	2	—	16
2013	5	136	20
2014	6	210	13
2015	3	115	13
2016	4	258	27
2017	1	—	39
2018	1	—	63
2019	4	265	56
2020	1	—	62
2021	3	149	85
2022	1	—	38
2023	3	251	34
2024	0	—	14
2025	3	84	5
2026	2	—	—

What is it indicated for?

The Sharp Chute TM is an over-the-counter, single-use, disposable, non-sterile sharps container intended to be used with medical sharps including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in any area requiring sharps collection prior to their final disposal.

When the container is filled to the max-capacity indicator, it is intended to be permanently locked and ultimately disposed of.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091690 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091690: Sharp Chute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091690

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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