510(k) Report

510(k) · Cleared

Cleared

Cricket

K955304510(k) TraditionalCleared May 16, 1996178-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Microvena Corp. · DQX Wire, Guide, Catheter

Cleared on May 16, 1996 as substantially equivalent to K862567 (Advanced Cardiovascular Systems, Inc., 1986) and 1 other predicate after a 178-day review. Its family tree reaches back 1 generation to 1986.

Decided
May 16, 1996
Review
178 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K862567 (1986). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestorK862567 · Acs Wire Shaper · Advanced Cardiovascular Systems, Inc. · 19861986198819901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K862567 · Acs Wire Shaper · Advanced Cardiovascular Systems, Inc. · 19860
  1. Root · 1 generation backK862567 Acs Wire ShaperAdvanced Cardiovascular Systems, Inc. · 1986
  2. This deviceK955304 CricketMicrovena Corp. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K862567Acs Wire ShaperAdvanced Cardiovascular Systems, Inc.1986—
0 (this device)K955304CricketMicrovena Corp.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
FIG. 1 — Lineage of K955304, 1986–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DQX? 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 DQX device

  1. #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K862567Acs Wire Shaper
Summary page 1
…November 10, 1995 CRICKET™ Multipurpose Steering Device and Tip Shaper Steering Device and Guide Wire Shaping Device Steering Device and Wire Shaper ACS Wire Shaper (K862567) MICROVENA Microtorquer pin vise (K922060) The CRICKET™ is intended to be used as a steering mechanism for guidewires. The oppos…
Advanced Cardiovascular Systems, Inc.1986—
*K922060.25' Ultra-Select Guidewire
Summary page 1
…Steering Device and Tip Shaper Steering Device and Guide Wire Shaping Device Steering Device and Wire Shaper ACS Wire Shaper (K862567) MICROVENA Microtorquer pin vise (K922060) The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar…
Microvena Corp.1993—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

What is it indicated for?

The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Microvena Corp.

18 FDA decisions under this applicant name. See the company

  • K991898Ultra-Select Guidewire, Hytek GuidewireMicrovena Corp. · 1999
  • K991194Modification to Ultra-Select GuidewireMicrovena Corp. · 1999
  • K982657Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model AK 100Microvena Corp. · 1998
  • K970668The Amplantz Goose Neck MicrosnareMicrovena Corp. · 1998
  • K972511Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 19981 recall

Recent decisions in DQX

The DQX category page

  • K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med Corporation · 2026
  • K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026
  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  • K253667Accoat Guide WireSp Medical A/S · 2026
  • K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026

https://510kreport.com/device/K955304 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955304: Cricket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955304

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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