510(k) · Cleared
ClearedQlicksmart BladeFlask UNIVERSAL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qlicksmart Pty, Ltd. · MMK Container, Sharps
Cleared on Jun 22, 2022 as substantially equivalent to K983367 (Handren Assoc., 1998) after a 265-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jun 22, 2022
- Review
- 265 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983367 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK983367 QlicksmartHandren Assoc. · 1998
- This deviceK213274 Qlicksmart BladeFlask UNIVERSALQlicksmart Pty, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983367 | Qlicksmart | Handren Assoc. | 1998 | — |
| 0 (this device) | K213274 | Qlicksmart BladeFlask UNIVERSAL | Qlicksmart Pty, Ltd. | 2022 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983367 | QlicksmartSummary page 5…ication Name: Hypodermic single lumen needle (21 CFR 880.5570) Regulatory Class: II Product Code: MMK III. PREDICATE DEVICE Predicate Device 510(k) application number: K983367 Original Name of the legally marketed predicate device was QLICKSMART®, Current trading name of the legally marketed predicate de… | 1998 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function intended to permit the safe removal of scalpel blades from most currently available scalpel handles and contain the blade immediately upon removal to eliminate the need for further handling prior to be disposed as medical waste while allowing the user to monitor its use to see when it is becoming full and will need changing. Scalpel handles compatible…
Read the full statement (191 words)
The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function intended to permit the safe removal of scalpel blades from most currently available scalpel handles and contain the blade immediately upon removal to eliminate the need for further handling prior to be disposed as medical waste while allowing the user to monitor its use to see when it is becoming full and will need changing. Scalpel handles compatible with the Qlicksmart BladeFlask PLUS include:
Swann Morton sizes 3, 4, 5, 6, 7, 8, and 9
Lawton size 4
Martin sizes 3, 4, and 7
Aesculap sizes 3, 4, 6, and 7
Sayco sizes 3, 4, and 5
Smic sizes 3 and 4
Nopa sizes 3 and 4
AB Stainless size 4
Lance sizes 3 and 4
Pro-Med sizes 3 and 4
Paragon sizes 3 and 4
Rocket size 5
Conqueror size 3
Feather sizes 3, 4, and 7
LRI sizes 3 and 4
Generic handle size 4
L-dent
Medesy size 5
Jakobi size 4
CS size 5
Helmut Zepf
Scalpel handles known to be incompatible with the Qlicksmart BladeFlask PLUS include:
Beaver type handles
Disposable handles
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213274: Qlicksmart BladeFlask UNIVERSAL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213274
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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