510(k) · Cleared
ClearedQlicksmart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Handren Assoc. · MMK Container, Sharps
Cleared on Nov 6, 1998 after a 43-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Nov 6, 1998
- Review
- 43 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983367 QlicksmartHandren Assoc. · 1998
- Descendant · cites it directly · 0 of its ownK213274 Qlicksmart BladeFlask UNIVERSALQlicksmart Pty, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213274Qlicksmart BladeFlask UNIVERSALQlicksmart Pty, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983367 | Qlicksmart | Handren Assoc. | 1998 | — |
| +1 | K213274 | Qlicksmart BladeFlask UNIVERSAL | Qlicksmart Pty, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| K213274 | Qlicksmart BladeFlask UNIVERSAL | 2022 | 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, K213274 (Qlicksmart Pty, Ltd., 2022) 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?
1. "Permits the safe and simple removal of scalpel blades from most commonly used scalpel handles" 2. "Safely contains the blade immediately upon removal, eliminating the need for further handling prior to disposal" 3. "The counter allows the user to monitor its use to see when it is pecoming full and will need changing™" 4. “Scalpel handles compatible with the QLICKSMART® include: Swann Morton Blade sizes 3, 4, 7 and 9 Lawton Blade sizes 3 and 4 Martin…
Read the full statement (175 words)
1. "Permits the safe and simple removal of scalpel blades from most commonly used scalpel handles"
2. "Safely contains the blade immediately upon removal, eliminating the need for further handling prior to disposal"
3. "The counter allows the user to monitor its use to see when it is pecoming full and will need changing™"
4. “Scalpel handles compatible with the QLICKSMART® include:
Swann Morton Blade sizes 3, 4, 7 and 9
Lawton Blade sizes 3 and 4
Martin Blade sizes 3, 4 and 7
Smic Blade sizes 3 and 4
Aesculap Blade sizes 3, 3L, 4 and 7
Sayco Blade sizes 3, 4 and 5
Nopa Blade sizes 3 and 4
Lance Blade sizes 3 and 4
Congueror Blade size 3
Pro-Med Blade sizes 3 and 4
Paragon-Blade sizes 3 and 4
Feather Blade size 7
Rocket Blade size 5
Generic Blade size 4
ab stainless Blade size 4
LRI Blade size 4
Jakobi Blade Size 4"
5. "Scalpel handles known to be incompatible with the QLICKSMART® include:
Barron Handle
Beaver Type Handles
Disposable Handles."
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983367: Qlicksmart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983367
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