510(k) Report

510(k) · Cleared

Cleared

Rotablator, Modification

K933238510(k) TraditionalCleared Aug 24, 199370-day reviewClass II21 CFR 870.4875

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

Heart Technology, Inc. · MCW Catheter, Peripheral, Atherectomy

Cleared on Aug 24, 1993 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 40 later devices descend from it.

Decided
Aug 24, 1993
Review
70 days
Class
Class II
Product code
MCW
Recalls
None
Predicates
0

40 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2004: 1 descendant cleared2005: 3 descendants cleared2006: 1 descendant cleared2017: 4 descendants cleared2013: 2 descendants cleared2008: 1 descendant cleared2011: 2 descendants cleared2010: 2 descendants cleared2014: 2 descendants cleared2007: 1 descendant cleared2022: 6 descendants cleared2021: 2 descendants cleared2009: 1 descendant cleared2024: 2 descendants cleared2018: 2 descendants cleared2015: 1 descendant cleared2025: 2 descendants cleared2020: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK933238 Rotablator, ModificationHeart Technology, Inc. · 1993
  2. Descendant · cites it directly · 36 of its ownK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
  3. Descendant · 2 generations on · 25 of its ownK043465 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005
  4. Descendant · 2 generations on · 24 of its ownK052296 Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005
  5. Descendant · 3 generations on · 23 of its ownK052514 Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151…Spectranetics Corp. · 2005
  6. Descendant · 3 generations on · 22 of its ownK071227 Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX)…Spectranetics Corp. · 2007 · Recalled

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2004: 12005: 32006: 12007: 12008: 12009: 12010: 22011: 22012: 12013: 22014: 22015: 12017: 42018: 22020: 12021: 22022: 62023: 22024: 22025: 22026: 1
2004high 6 (2022) · low 0 (2016)2026

Most influential descendants

Showing 5 of 40 · See all
  • K040067Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004 · cites it directly36descendants
  • K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005 · 2 generations on25descendants
  • K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005 · 2 generations on24descendants
  • K052514Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156…Spectranetics Corp. · 2005 · 3 generations on23descendants
  • K071227Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX)…Spectranetics Corp. · 2007 · 3 generations on22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933238Rotablator, ModificationHeart Technology, Inc.1993—
+1K040067Clirpath Excimer Laser CatheterSpectranetics Corp.2004—
+2K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp.2005—
+2K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp.2005—
+3K052514Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152…Spectranetics Corp.2005—
+3K071227Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM…Spectranetics Corp.20071

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200530
200610
200710
200810
200910
201020
201120
201210
201320
201420
201510
201740
201820
202010
202120
202260
202320
202420
202520
202610
FIG. 1 — Lineage of K933238, 1993–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MCW? 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 MCW device

  1. #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (40)

See all 40

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040067Clirpath Excimer Laser CatheterSpectranetics Corp.200436
K121774Rotablator Rotational Atherectomy System with Peripheral Rotalink PlusBoston Scientific Corp20122

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, K040067 (Spectranetics Corp., 2004) has gone furthest, with 36 descendants of its own.

How does its category compare?

All MCW devices

MCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MCW

3in 2025

2007: 52008: 62009: 82010: 62011: 62012: 52013: 52014: 72015: 62016: 52017: 72018: 82019: 32020: 22021: 62022: 62023: 42024: 32025: 32026 (partial year): 1
2007high 8 (2009) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MCW

46in 2025

2007: 43 days median2008: 33 days median2009: 27 days median2010: 30 days median2011: 39 days median2012: 29 days median2013: 30 days median2014: 117 days median2015: 30 days median2016: 60 days median2017: 91 days median2018: 103 days median2019: 112 days median2021: 119 days median2022: 69 days median2023: 104 days median2024: 41 days median2025: 46 days median
2007high 119 (2021) · low 27 (2009)2026

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

Recalls per year · MCW

2in 2024

2007: 22008: 12009: 32010: 12016: 22017: 22021: 2, 2 Class I2022: 2, 2 Class I2023: 12024: 2
2007high 3 (2009) · low 0 (2011)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · MCW

677in 2025

2007: 502008: 1152009: 1052010: 1672011: 2042012: 1942013: 1342014: 2102015: 3772016: 4092017: 4152018: 5372019: 6182020: 6312021: 7342022: 5662023: 5742024: 6772025: 677
2007high 734 (2021) · low 50 (2007)2025

MAUDE reports naming product code MCW, 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
2007543250
20086331115
20098273105
20106301167
20116390204
20125290194
20135300134
201471170210
20156300377
20165602409
20177912415
201881030537
201931120618
20202—0631
202161192 (2)734
20226692 (2)566
202341041574
20243412677
20253460677
20261—0—

More from Heart Technology, Inc.

4 FDA decisions under this applicant name. See the company

  • K914581Heart Technology WireclipHeart Technology, Inc. · 1992
  • K913450Heart Technology Rotablator WireclipHeart Technology, Inc. · 1991
  • K901206RotablatorHeart Technology, Inc. · 1990

Recent decisions in MCW

The MCW category page

  • K260244Auryon Atherectomy SystemEximo Medical · 2026
  • K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc., · 2025
  • K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics · 2025
  • K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 20251 Class I recall
  • K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc., · 2024

https://510kreport.com/device/K933238 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933238: Rotablator, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933238

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026