510(k) Report

510(k) · Cleared

Cleared

Uram Ophthalmic Laser Endoscope

K910532510(k) TraditionalCleared May 28, 1991109-day reviewClass II21 CFR 886.4390

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

Martin S. Knopf Assoc., Inc. · HQF Laser, Ophthalmic

Cleared on May 28, 1991 after a 109-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 28, 1991
Review
109 days
Class
Class II
Product code
HQF
Recalls
None
Predicates
0

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

Descendants, by year cleared 2025: 1 descendant cleared1990200020102020
  1. This deviceK910532 Uram Ophthalmic Laser EndoscopeMartin S. Knopf Assoc., Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK240615 Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 2025 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910532Uram Ophthalmic Laser EndoscopeMartin S. Knopf Assoc., Inc.1991—
+1K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.20251

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K910532, 1991–2025Source: 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 HQF? 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 HQF device

  1. #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.20250

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, K240615 (Beaver-Visitec International, Inc., 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HQF devices

HQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQF

3in 2025

2007: 42008: 32009: 72010: 22011: 42012: 52013: 62014: 32015: 42016: 32017: 32018: 12019: 42020: 42021: 12022: 72023: 52024: 32025: 32026 (partial year): 2
2007high 7 (2009) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQF

264in 2025

2007: 198 days median2008: 28 days median2009: 115 days median2011: 128 days median2012: 179 days median2013: 225 days median2014: 215 days median2015: 295 days median2016: 271 days median2017: 189 days median2019: 107 days median2020: 53 days median2022: 86 days median2023: 155 days median2024: 167 days median2025: 264 days median
2007high 295 (2015) · low 28 (2008)2026

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

Recalls per year · HQF

1in 2025

2007: 22008: 12009: 22010: 32011: 52012: 12013: 22014: 42025: 1
2007high 5 (2011) · low 0 (2015)2026

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

Adverse event reports per year · HQF

106in 2025

2007: 602008: 342009: 332010: 432011: 262012: 412013: 392014: 582015: 802016: 1082017: 772018: 822019: 662020: 722021: 1002022: 1112023: 922024: 752025: 106
2007high 111 (2022) · low 26 (2011)2025

MAUDE reports naming product code HQF, 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
20074198260
2008328134
20097115233
20102—343
20114128526
20125179141
20136225239
20143215458
20154295080
201632710108
20173189077
20181—082
20194107066
2020453072
20211—0100
20227860111
20235155092
20243167075
202532641106
20262—0—

More from Martin S. Knopf Assoc., Inc.

2 FDA decisions under this applicant name. See the company

  • K942214H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994

Recent decisions in HQF

The HQF category page

  • K252979Voyager DSLT (430840610)Belkin Vision, Ltd. · 2026
  • K251507Integre LioQuantel Medical · 2026
  • K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
  • K243014EyeQ nanoECPEyeq, Inc. · 2025
  • K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 20251 recall

https://510kreport.com/device/K910532 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910532: Uram Ophthalmic Laser Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910532

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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