510(k) · Cleared
ClearedFitpack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asp Plastics Pty, Ltd. · MMK Container, Sharps
Cleared on Jul 25, 2006 after a 200-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 25, 2006
- Review
- 200 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK060037 FitpackAsp Plastics Pty, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK252637 Community Containers (Flap and Daisy)Keter Canada, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252637Community Containers (Flap and Daisy)Keter Canada, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060037 | Fitpack | Asp Plastics Pty, Ltd. | 2006 | — |
| +1 | K252637 | Community Containers (Flap and Daisy) | Keter Canada, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252637 | Community Containers (Flap and Daisy) | 2025 | 0 |
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, K252637 (Keter Canada, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Fitpack® DS-128 and DS-130 Fit Tank Products are intended to be used for the collection, transportation and disposal of hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used hypodermic needles and syringes. The Fitpack® DS-047 Disposa Safe Clean Up, DS-091 Disposa Safe Products are intended to be used for the…
Read the full statement (177 words)
The Fitpack® DS-128 and DS-130 Fit Tank Products are intended to be used for the collection, transportation and disposal of hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used hypodermic needles and syringes.
The Fitpack® DS-047 Disposa Safe Clean Up, DS-091 Disposa Safe Products are intended to be used for the collection, transportation and disposal of I ml insulin hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used I ml insulin hypodermic needles and syringes.
The Fitpack® DS-046 mini fit tube Product is intended to be used for the collection, transportation and disposal of I ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used I ml and 2 ml hypodermic needles and syringes.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060037 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060037: Fitpack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060037
Report an extraction error
Are you the manufacturer?
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