510(k) Report

510(k) · Cleared

Cleared

Disk Whisk Cutting Device (Conical, Elliptical and Ball Head)

K971342510(k) TraditionalCleared Jul 8, 199789-day reviewClass I21 CFR 878.4820

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

Disk Whisk, Inc. · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Cleared on Jul 8, 1997 after an 89-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Jul 8, 1997
Review
89 days
Class
Class I
Product code
HWE
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared1995200020052010201520202025
  1. This deviceK971342 Disk Whisk Cutting Device (Conical, Elliptical and Ball Head)Disk Whisk, Inc. · 1997
  2. Descendant · cites it directly · 0 of its ownK081240 Tiger Discectomy DeviceSpinal Devices, LLC · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K081240Tiger Discectomy DeviceSpinal Devices, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K971342Disk Whisk Cutting Device (Conical, Elliptical and Ball Head)Disk Whisk, Inc.1997—
+1K081240Tiger Discectomy DeviceSpinal Devices, LLC2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K971342, 1997–2009Source: 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 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 HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

NumberDeviceApplicantDecidedDescendants
K081240Tiger Discectomy DeviceSpinal Devices, LLC20090

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, K081240 (Spinal Devices, LLC, 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HWE devices

HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWE

1in 2015

2007: 12011: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWE

Too few HWE 510(k)s in any year since 2007 to give a median.

Recalls per year · HWE

1in 2017

2009: 42010: 22011: 22013: 12014: 32015: 52016: 22017: 1
2007high 5 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWE

2,848in 2025

2007: 1232008: 722009: 1802010: 2972011: 1382012: 2212013: 1,2432014: 3,7942015: 5,5672016: 4,9742017: 5,0742018: 3,5892019: 3,4522020: 3,2482021: 3,1402022: 3,3272023: 3,3972024: 3,6862025: 2,848
2007high 5,567 (2015) · low 72 (2008)2025

MAUDE reports naming product code HWE, 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
20071—0123
20080—072
20090—4180
20100—2297
20111—2138
20120—0221
20130—11,243
20140—33,794
20151—55,567
20160—24,974
20170—15,074
20180—03,589
20190—03,452
20200—03,248
20210—03,140
20220—03,327
20230—03,397
20240—03,686
20250—02,848
20260—0—

What is it indicated for?

The product is indicated for use in endoscopic and non-endoscopic orthopedic procedures, to assist in the removal of fibrous disk material in the spine and for the decortication of bone.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

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The HWE category page

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https://510kreport.com/device/K971342 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971342: Disk Whisk Cutting Device (Conical, Elliptical and Ball Head).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971342

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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