510(k) · Cleared
ClearedAP Medical Sharps Containers 0,6-12 LT.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.B.M. Italia S.P.A · MMK Container, Sharps
Cleared on Apr 2, 2008 as substantially equivalent to K961878 (Winfield Industries, 1996) and 1 other predicate after a 303-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 2, 2008
- Review
- 303 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945197 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK945197 The Sharps Collection and Disposal SystemDevon Industries, Inc. · 1994
- This deviceK071517 AP Medical Sharps Containers 0,6-12 LT.A.B.M. Italia S.P.A · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945197 | The Sharps Collection and Disposal System | Devon Industries, Inc. | 1994 | — |
| 0 (this device) | K071517 | AP Medical Sharps Containers 0,6-12 LT. | A.B.M. Italia S.P.A | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961878 | Sharps-TainerSummary page 2…3) Equivalent device being legally marketed: For PBS Line: Trade name: Sharps-Tainer Manufactured by: WINFIELD INDUSTRIES 510K approval Number: K961878 For CS and Nursy Line: Trade name: The sharps collection and disposal system Manufactured by: DEVON INDUSTRIE… | 1996 |
| * | K945197 | The Sharps Collection and Disposal System | 1994 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MMK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMK
84in 2025
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 63 | 0 | 5 |
| 2008 | 6 | 61 | 0 | 21 |
| 2009 | 4 | 100 | 0 | 9 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 5 | 136 | 0 | 20 |
| 2014 | 6 | 210 | 0 | 13 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 4 | 258 | 0 | 27 |
| 2017 | 1 | — | 0 | 39 |
| 2018 | 1 | — | 0 | 63 |
| 2019 | 4 | 265 | 0 | 56 |
| 2020 | 1 | — | 0 | 62 |
| 2021 | 3 | 149 | 0 | 85 |
| 2022 | 1 | — | 0 | 38 |
| 2023 | 3 | 251 | 0 | 34 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 3 | 84 | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
AP Medical sharps containers are intended for use by healthcare providers such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities for safe disposal of sharps such as Needles, Scalpels, Lancets and other Sharp Instruments.
Three different lines are offered to our customers and end users:
PBS line - disposable round containers with access inlets on the lid, for sharps disposal
CS line - disposable square containers with rotating lid for sharps disposal
NURSY line - disposable square containers with hermetic permanent closure for sharps disposal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071517: AP Medical Sharps Containers 0,6-12 LT..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071517
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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