510(k) Report

510(k) · Decided

Decided

Laser Endoscope Disc Decompression Kits

K913136510(k) TraditionalDecided Nov 1, 1991108-day reviewClass II21 CFR 878.4370

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

Medical Laser, Inc. · LRO General Surgery Tray

Cleared on Nov 1, 1991 after a 108-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 484 later devices descend from it.

Decided
Nov 1, 1991
Review
108 days
Class
Class II
Product code
LRO
Recalls
None
Predicates
0

484 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1999: 1 descendant cleared1998: 2 descendants cleared2005: 5 descendants cleared2013: 24 descendants cleared2014: 23 descendants cleared2006: 4 descendants cleared2009: 8 descendants cleared2012: 23 descendants cleared2001: 2 descendants cleared2002: 8 descendants cleared2008: 18 descendants cleared2016: 33 descendants cleared2010: 20 descendants cleared2007: 4 descendants cleared2015: 24 descendants cleared2022: 30 descendants cleared2011: 18 descendants cleared2017: 18 descendants cleared2024: 31 descendants cleared2023: 24 descendants cleared2021: 20 descendants cleared2018: 22 descendants cleared2020: 27 descendants cleared2025: 42 descendants cleared2003: 3 descendants cleared2004: 3 descendants cleared2019: 16 descendants cleared2026: 30 descendants cleared1990200020102020
  1. This deviceK913136 Laser Endoscope Disc Decompression KitsMedical Laser, Inc. · 1991
  2. Descendant · cites it directly · 483 of its ownK960413 Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc. · 1996
  3. Descendant · 2 generations on · 351 of its ownK980685 Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc. · 1998
  4. Descendant · 2 generations on · 350 of its ownK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
  5. Descendant · 3 generations on · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
  6. Descendant · 2 generations on · 225 of its ownK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · Recalled

Showing 5 of 484 descendants. See all descendants

Descendants cleared per year

1996: 11998: 21999: 12001: 22002: 82003: 32004: 32005: 52006: 42007: 42008: 182009: 82010: 202011: 182012: 232013: 242014: 232015: 242016: 332017: 182018: 222019: 162020: 272021: 202022: 302023: 242024: 312025: 422026: 30
1996high 42 (2025) · low 0 (1997)2026

Most influential descendants

Showing 5 of 484 · See all
  • K960413Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc. · 1996 · cites it directly483descendants
  • K980685Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc. · 1998 · 2 generations on351descendants
  • K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc. · 1999 · 2 generations on350descendants
  • K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · 3 generations on342descendants
  • K050738FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · 2 generations on225descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913136Laser Endoscope Disc Decompression KitsMedical Laser, Inc.1991—
+1K960413Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc.1996—
+2K980685Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc.1998—
+2K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO…Lumenis, Inc.1999—
+3K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis20012
+2K050738FT Fiber Optic Delivery SystemsFibertech GmbH20055

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199820
199910
200120
200280
200330
200430
200550
200640
200740
2008180
200980
2010200
2011180
2012230
2013240
2014230
2015240
2016330
2017180
2018220
2019160
2020270
2021200
2022300
2023240
2024310
2025420
2026300
FIG. 1 — Lineage of K913136, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 LRO? 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 LRO device

  1. #1 K212258 Medline Cardiovascular Procedure Kitscore 2.5 · 1 generation · no Class I recall
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? (484)

See all 484

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960413Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc.1996483

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, K960413 (Lumenis, Inc., 1996) has gone furthest, with 483 descendants of its own.

How does its category compare?

All LRO devices

LRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRO

1in 2022

2021: 12022: 1
2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRO

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

Recalls per year · LRO

14in 2025

2007: 12009: 22010: 12011: 112012: 42013: 11, 11 Class I2014: 59, 58 Class I2015: 52016: 42017: 292018: 312019: 42020: 32021: 32022: 1922023: 18, 2 Class I2024: 60, 1 Class I2025: 14, 5 Class I2026 (partial year): 75, 16 Class I
2007high 192 (2022) · low 0 (2008)2026

Class I (93 since 2007) Class II/III not classified

Adverse event reports per year · LRO

5,488in 2025

2007: 82008: 82009: 52010: 232011: 172012: 642013: 252014: 592015: 6282016: 8052017: 5232018: 3842019: 4062020: 7672021: 9202022: 1,1342023: 1,9132024: 3,0312025: 5,488
2007high 5,488 (2025) · low 5 (2009)2025

MAUDE reports naming product code LRO, 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
20070—18
20080—08
20090—25
20100—123
20110—1117
20120—464
20130—11 (11)25
20140—59 (58)59
20150—5628
20160—4805
20170—29523
20180—31384
20190—4406
20200—3767
20211—3920
20221—1921,134
20230—18 (2)1,913
20240—60 (1)3,031
20250—14 (5)5,488
20260—75 (16)—

More from Medical Laser, Inc.

11 FDA decisions under this applicant name. See the company

  • K912265Medilase Semi-Rigid Instrod Sheath Series AE1000Medical Laser, Inc. · 1991
  • K912447Series 5000 Endoscope Console Models 5100 and 5200Medical Laser, Inc. · 1991
  • K912089Modified Series 2100 EndoscopesMedical Laser, Inc. · 1991
  • K901464Medilase Series 2200 EndoscopeMedical Laser, Inc. · 1990
  • K900894Medilase Series 2100 EndoscopeMedical Laser, Inc. · 1990

Recent decisions in LRO

The LRO category page

  • K213481Medline General Surgery TrayMedline Industries, Inc. · 202211 Class I recalls
  • K212258Medline Cardiovascular Procedure KitMedline Industries, Inc. · 2021
  • K041080Surgical Drape Kit - D.I.R.R.a. SRLD.I.R.R.a. S.R.L. · 2004
  • K030721Quick-Tap Paracentesis Tray, Kit & NeedleBallard Medical Products · 2003
  • K023276Amsino Tracheostomy Care TrayAmsino International, Inc. · 2002

https://510kreport.com/device/K913136 · printed Nov 4, 2026

Cite this page

510(k) Report. “K913136: Laser Endoscope Disc Decompression Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913136

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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