510(k) · Cleared
ClearedArvik Laparoscopic Aspiration Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arvik Enterprises/ Mini Lap Technologies · GAA Needle, Aspiration And Injection, Disposable
Cleared on Jun 15, 2011 as substantially equivalent to K983200 (Ximed/Prosure/Injectx, 1998) after a 308-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jun 15, 2011
- Review
- 308 days
- Class
- Class I
- Product code
- GAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983200 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK983200 Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexXimed/Prosure/Injectx · 1998
- This deviceK102274 Arvik Laparoscopic Aspiration InstrumentArvik Enterprises/ Mini Lap Technologies · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi Flex | Ximed/Prosure/Injectx | 1998 | — |
| 0 (this device) | K102274 | Arvik Laparoscopic Aspiration Instrument | Arvik Enterprises/ Mini Lap Technologies | 2011 | — |
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 GAA? 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 GAA device
- #1 K223625 CapnoSpot™ Pneumothorax Decompression Indicatorscore 5.1 · 1 generation · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexSummary page 1…92(a)(3)1 Ximed Prosure Inj ection/Aspi ration Needle Probes/Devices (Ximed Medical/Prose, Inc. - San Jose, CA) Product Code: GAA Premarket Notification: K983200 Description of the Device 121 CER 807.92(a)(4)J The RaviNeedle Aspiration Instrument is stainless steel needle approximately 12… | 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 GAA devicesGAA Needle, Aspiration And Injection, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GAA
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAA
Too few GAA 510(k)s in any year since 2007 to give a median.
Recalls per year · GAA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAA
348in 2025
MAUDE reports naming product code GAA, 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 | 0 | — | 0 | 12 |
| 2008 | 0 | — | 1 | 32 |
| 2009 | 0 | — | 2 | 20 |
| 2010 | 0 | — | 2 | 18 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 0 | 33 |
| 2014 | 0 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 0 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 122 |
| 2019 | 0 | — | 10 | 153 |
| 2020 | 0 | — | 0 | 102 |
| 2021 | 0 | — | 5 | 108 |
| 2022 | 0 | — | 2 | 74 |
| 2023 | 1 | — | 0 | 118 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 0 | — | 0 | 348 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Mini-Lap Technologies RaviNeedle Aspiration Needle is indicated for use in endoscopic and
open surgical procedures where it is appropriate to aspirate fluids and retain tissue during
aspiration of fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102274: Arvik Laparoscopic Aspiration Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102274
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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