510(k) · Cleared
ClearedVacLok AT Vacuum Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · PUR Vacuum Syringe
Cleared on Jul 27, 2017 as substantially equivalent to K070936 (Welmed, Inc., 2007) after a 218-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Jul 27, 2017
- Review
- 218 days
- Class
- Class II
- Product code
- PUR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980580 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- 2 generations backK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
- 1 generation backK070936 Welmed Hypodermic SyringeWelmed, Inc. · 2007
- This deviceK163597 VacLok AT Vacuum SyringeMerit Medical Systems, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK233069 Removal System Large Bore 60 cc SyringeInari Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233069Removal System Large Bore 60 cc SyringeInari Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980580 | Becton Dickinson Syringes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| −2 | K024052 | Merit Medical 1-ML Syringe | Merit Medical Systems, Inc. | 2003 | — |
| −1 | K070936 | Welmed Hypodermic Syringe | Welmed, Inc. | 2007 | — |
| 0 (this device) | K163597 | VacLok AT Vacuum Syringe | Merit Medical Systems, Inc. | 2017 | — |
| +1 | K233069 | Removal System Large Bore 60 cc Syringe | Inari Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 PUR? 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 PUR device
- #1 K233069 Removal System Large Bore 60 cc Syringescore 8.0 · 4 generations · no Class I recall
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.
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 |
|---|---|---|---|
| K233069 | Removal System Large Bore 60 cc Syringe | 2024 | 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233069 (Inari Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K070936.
How does its category compare?
All PUR devicesPUR Vacuum Syringe: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PUR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PUR
Too few PUR 510(k)s in any year since 2007 to give a median.
Recalls per year · PUR
No recall names PUR since 2007.
Adverse event reports per year · PUR
No MAUDE report names PUR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VacLok™ AT Vacuum Syringe is used to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g. thrombus, abscess fluid, bile, urine etc.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163597 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163597: VacLok AT Vacuum Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163597
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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