510(k) Report

510(k) · Cleared

Cleared

Sola Schultze-Crock Opthalmoscope

K760771510(k) TraditionalCleared Oct 15, 197611-day reviewClass II21 CFR 886.1570

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

Codman & Shurtleff, Inc. · HLJ Ophthalmoscope, Battery-Powered

Cleared on Oct 15, 1976 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Oct 15, 1976
Review
11 days
Class
Class II
Product code
HLJ
Recalls
None
Predicates
0

11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1997: 1 descendant cleared2001: 1 descendant cleared1999: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2000: 1 descendant cleared2018: 1 descendant cleared2003: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared19801990200020102020
  1. This deviceK760771 Sola Schultze-Crock OpthalmoscopeCodman & Shurtleff, Inc. · 1976
  2. Descendant · cites it directly · 8 of its ownK983758 Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998
  3. Descendant · cites it directly · 6 of its ownK970050 Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997
  4. Descendant · 2 generations on · 4 of its ownK131500 Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014
  5. Descendant · 2 generations on · 3 of its ownK173271 Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017
  6. Descendant · 3 generations on · 2 of its ownK180914 Aesculap Slim Clip ApplierAesculap, Inc. · 2018

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 12000: 12001: 12003: 12014: 12017: 12018: 12021: 12022: 1
1997high 1 (1997) · low 0 (2002)2026

Most influential descendants

Showing 5 of 11 · See all
  • K983758Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998 · cites it directly8descendants
  • K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997 · cites it directly6descendants
  • K131500Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014 · 2 generations on4descendants
  • K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017 · 2 generations on3descendants
  • K180914Aesculap Slim Clip ApplierAesculap, Inc. · 2018 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K760771Sola Schultze-Crock OpthalmoscopeCodman & Shurtleff, Inc.1976—
+1K983758Yasargil Titanium Aneurysm ClipsAesculap, Inc.1998—
+1K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc.1997—
+2K131500Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc.2014—
+2K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc.2017—
+3K180914Aesculap Slim Clip ApplierAesculap, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200010
200110
200310
201410
201710
201810
202110
202210
FIG. 1 — Lineage of K760771, 1976–2022Source: 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 HLJ? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K983758Yasargil Titanium Aneurysm ClipsAesculap, Inc.19988
K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc.19976
K013136Aneurysm ClipsGistlstrasse20010

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, K983758 (Aesculap, Inc., 1998) has gone furthest, with 8 descendants of its own.

How does its category compare?

All HLJ devices

HLJ Ophthalmoscope, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HLJ

2in 2015

2007: 12010: 12013: 32014: 12015: 2
2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HLJ

140in 2013

2013: 140 days median
2007high 140 (2013)2026

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

Recalls per year · HLJ

No recall names HLJ since 2007.

Adverse event reports per year · HLJ

1in 2023

2020: 12022: 22023: 1
2007high 2 (2022) · low 0 (2007)2025

MAUDE reports naming product code HLJ, 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—00
20080—00
20090—00
20101—00
20110—00
20120—00
2013314000
20141—00
20152—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—02
20230—01
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K760771: Sola Schultze-Crock Opthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760771

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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