510(k) Report

510(k) · Cleared

Cleared

Laser Bronchoscope

K822136510(k) TraditionalCleared Aug 16, 198227-day reviewClass II21 CFR 874.4680

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

Laser Industries of Tel Aviv · EOQ Bronchoscope (Flexible Or Rigid)

Cleared on Aug 16, 1982 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 377 later devices descend from it.

Decided
Aug 16, 1982
Review
27 days
Class
Class II
Product code
EOQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2004: 3 descendants cleared2007: 9 descendants cleared2025: 41 descendants cleared2008: 13 descendants cleared2006: 3 descendants cleared2005: 2 descendants cleared2003: 3 descendants cleared2009: 7 descendants cleared2012: 8 descendants cleared2015: 12 descendants cleared2011: 13 descendants cleared2013: 11 descendants cleared2021: 19 descendants cleared2010: 7 descendants cleared2014: 12 descendants cleared2022: 36 descendants cleared2024: 41 descendants cleared2016: 13 descendants cleared2018: 22 descendants cleared2020: 28 descendants cleared2017: 12 descendants cleared2023: 25 descendants cleared2019: 10 descendants cleared2026: 26 descendants cleared19801990200020102020
  1. This deviceK822136 Laser BronchoscopeLaser Industries of Tel Aviv · 1982
  2. Descendant · cites it directly · 376 of its ownK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
  3. Descendant · 2 generations on · 323 of its ownK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
  4. Descendant · 2 generations on · 318 of its ownK031795 Reliant Laser SystemReliant Technologies, Inc. · 2003
  5. Descendant · 2 generations on · 316 of its ownK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
  6. Descendant · 2 generations on · 284 of its ownK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005

Showing 5 of 377 descendants. See all descendants

Descendants cleared per year

2002: 12003: 32004: 32005: 22006: 32007: 92008: 132009: 72010: 72011: 132012: 82013: 112014: 122015: 122016: 132017: 122018: 222019: 102020: 282021: 192022: 362023: 252024: 412025: 412026: 26
2002high 41 (2024) · low 1 (2002)2026

Most influential descendants

Showing 5 of 377 · See all
  • K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc. · 2002 · cites it directly376descendants
  • K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003 · 2 generations on323descendants
  • K031795Reliant Laser SystemReliant Technologies, Inc. · 2003 · 2 generations on318descendants
  • K040617Reliant Laser System IIReliant Technologies, Inc. · 2004 · 2 generations on316descendants
  • K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005 · 2 generations on284descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K822136Laser BronchoscopeLaser Industries of Tel Aviv1982—
+1K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device…Lumenis, Inc.2002—
+2K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd.2003—
+2K031795Reliant Laser SystemReliant Technologies, Inc.2003—
+2K040617Reliant Laser System IIReliant Technologies, Inc.2004—
+2K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200330
200430
200520
200630
200790
2008130
200970
201070
2011130
201280
2013110
2014120
2015120
2016130
2017120
2018220
2019100
2020280
2021190
2022360
2023250
2024410
2025410
2026260
FIG. 1 — Lineage of K822136, 1982–2026Source: 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 EOQ? 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 EOQ device

  1. #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (377)

See all 377

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

NumberDeviceApplicantDecidedDescendants
K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc.2002376

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, K022060 (Lumenis, Inc., 2002) has gone furthest, with 376 descendants of its own.

How does its category compare?

All EOQ devices

EOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EOQ

20in 2025

2007: 22008: 22009: 32012: 22013: 42014: 32015: 62016: 32017: 42018: 72019: 112020: 102021: 152022: 112023: 122024: 132025: 202026 (partial year): 9
2007high 20 (2025) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EOQ

147in 2025

2009: 24 days median2013: 178 days median2014: 302 days median2015: 206 days median2016: 262 days median2017: 136 days median2018: 212 days median2019: 147 days median2020: 103 days median2021: 169 days median2022: 134 days median2023: 160 days median2024: 130 days median2025: 147 days median2026 (partial year): 206 days median
2007high 302 (2014) · low 24 (2009)2026

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

Recalls per year · EOQ

25in 2025

2011: 12012: 42016: 12019: 12020: 12021: 92022: 52023: 18, 4 Class I2024: 42025: 25, 24 Class I
2007high 25 (2025) · low 0 (2007)2026

Class I (28 since 2007) Class II/III not classified

Adverse event reports per year · EOQ

6,546in 2025

2007: 392008: 872009: 1142010: 1002011: 962012: 932013: 932014: 982015: 1322016: 2972017: 3372018: 2792019: 6542020: 5152021: 1,3582022: 2,5412023: 5,0642024: 6,0512025: 6,546
2007high 6,546 (2025) · low 39 (2007)2025

MAUDE reports naming product code EOQ, 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
20072—039
20082—087
20093240114
20100—0100
20110—196
20122—493
20134178093
20143302098
201562060132
201632621297
201741360337
201872120279
2019111471654
2020101031515
20211516991,358
20221113452,541
20231216018 (4)5,064
20241313046,051
20252014725 (24)6,546
202692060—

Recent decisions in EOQ

The EOQ category page

  • K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd. · 2026
  • K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S · 2026
  • K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U)…Flexicare Medical Limited. · 2026
  • K260382MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2026
  • K254037LungFlow Airway CatheterFree Flow Medical, Inc. · 2026

https://510kreport.com/device/K822136 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822136: Laser Bronchoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822136

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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