510(k) Report

510(k) · Cleared

Cleared

Endocam Camera Systems 5502/5507 with CR Camera Heads and Accessories

K982965510(k) TraditionalCleared Nov 23, 199890-day reviewClass I21 CFR 878.4160

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

Richard Wolf Medical Instruments Corp. · FWF Camera, Television, Endoscopic, Without Audio

Cleared on Nov 23, 1998 as substantially equivalent to K950502 (Richard Wolf Medical Instruments Corp., 1995) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.

Decided
Nov 23, 1998
Review
90 days
Class
Class I
Product code
FWF
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K942817 (1994). 2 ancestors in all. 11 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2003: 1 descendant cleared2008: 2 descendants cleared2013: 1 descendant cleared2005: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2021: 1 descendant clearedK942817 · CCD Endocam Office 5510 · Richard Wolf Medical Instruments Corp. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K942817 · CCD Endocam Office 5510 · Richard Wolf Medical Instruments Corp. · 19940+5
  1. Root · 1 generation backK942817 CCD Endocam Office 5510Richard Wolf Medical Instruments Corp. · 1994
  2. This deviceK982965 Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesRichard Wolf Medical Instruments Corp. · 1998
  3. Descendant · cites it directly · 10 of its ownK023659 1-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp. · 2003
  4. Descendant · 2 generations on · 7 of its ownK080977 3 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008
  5. Descendant · 2 generations on · 6 of its ownK130423 The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
  6. Descendant · 3 generations on · 4 of its ownK180583 Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018
  7. Descendant · 4 generations on · 2 of its ownK200617 Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic…Richard Wolf Medical Instruments Corporation · 2020

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12008: 22013: 12017: 12018: 12020: 12021: 12022: 12026: 1
2003high 2 (2008) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all
  • K0236591-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp. · 2003 · cites it directly10descendants
  • K0809773 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008 · 2 generations on7descendants
  • K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013 · 2 generations on6descendants
  • K180583Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018 · 3 generations on4descendants
  • K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…Richard Wolf Medical Instruments Corporation · 2020 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K942817CCD Endocam Office 5510Richard Wolf Medical Instruments Corp.1994—
0 (this device)K982965Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesRichard Wolf Medical Instruments Corp.1998—
+1K0236591-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp.2003—
+2K0809773 CCD Endocam 5550Richard Wolf Medical Instruments Corp.2008—
+2K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp.2013—
+3K180583Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation2018—
+4K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera…Richard Wolf Medical Instruments Corporation2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200820
201310
201710
201810
202010
202110
202210
202610
FIG. 1 — Lineage of K982965, 1994–2026Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FWF? 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
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K950502CCD Endocam 5501
Summary page 1
…and 5507 Common name: lassification Name: Endoscopic Video Camera System ndoscope and / or Accessories 510(k) Number Trade or proprietary or model name Manufacturer I K950502 1 CCD Endocam 1 Richard Wolf M.I.C. 2 K942817 2 CCD Endocam Office 2 Richard Wolf M.1.C, 3 3 3 4 4 4 5 5 5 1.0 Description The e…
Richard Wolf Medical Instruments Corp.1995—
*K942817CCD Endocam Office 5510
Summary page 1
…doscopic Video Camera System ndoscope and / or Accessories 510(k) Number Trade or proprietary or model name Manufacturer I K950502 1 CCD Endocam 1 Richard Wolf M.I.C. 2 K942817 2 CCD Endocam Office 2 Richard Wolf M.1.C, 3 3 3 4 4 4 5 5 5 1.0 Description The endoscopic video camera systems include a camer…
Richard Wolf Medical Instruments Corp.1994—

Also cleared against K950502: 3 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K0236591-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp.200310

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K023659 (Richard Wolf Medical Instruments Corp., 2003) has gone furthest, with 10 descendants of its own.
  • 3 other devices also cite its predicate K950502.

How does its category compare?

All FWF devices

FWF Camera, Television, Endoscopic, Without Audio: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FWF

FDA has decided no FWF device since 2007.

Median 510(k) review, days · FWF

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

Recalls per year · FWF

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FWF

27in 2025

2007: 12008: 62009: 12010: 52011: 22012: 12013: 62017: 42018: 92019: 402020: 232021: 282022: 402023: 252024: 202025: 27
2007high 40 (2019) · low 0 (2014)2025

MAUDE reports naming product code FWF, 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—21
20080—06
20090—01
20100—05
20110—02
20120—01
20130—06
20140—00
20150—00
20160—00
20170—04
20180—09
20190—040
20200—023
20210—028
20220—040
20230—025
20240—020
20250—027
20260—0—

What is it indicated for?

The 1 CCD Endocam 5502 and 3 CCD Endocam 5507 are designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions.

The camera head is classified as Cardiac Floating (CF) equipment with less than 10pA of leakage current. This permits its use for cardiac visualization procedures when used in conjunction with the proper instrumentation for entry into the cardiac system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K950502

3 other devices cite the same predicate.

  • K071292View MD Office System, Model 41066.5540Richard Wolf Medical Instruments Corp. · 2007
  • K0236591-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp. · 2003
  • K983279Endocam Camera Systems 5502 with Electronic CCD EndoscopeRichard Wolf Medical Instruments Corp. · 1998

More from Richard Wolf Medical Instruments Corp.

146 FDA decisions under this applicant name. See the company

  • P870080/S002Hulka Clip for Tubal OcclusionRichard Wolf Medical Instruments Corp. · 2016
  • K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp. · 2016
  • K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
  • K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
  • K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar…Richard Wolf Medical Instruments Corp. · 2012

Recent decisions in FWF

The FWF category page

  • K053412Flexiscope, Models 50MH and 50 MHCSchoelly Imaging, Inc. · 2006
  • K990154Karl Storz Direct Coupled Interface (Dci 5) Camera SystemKarl Storz Imaging, Inc. · 1999
  • K982754EC-1000-7 Digital Endoscopy Video Camera, Models EC 1000-7P (Pal) & EC 1000-7N (NTSC)A.Stein - Regulatory Affairs Consulting · 1999
  • K982397Ves 3001-M Complete Video Endoscopic SystemAngiolaz, Inc. · 1998
  • K982409VES 1501-MAngiolaz, Inc. · 1998

https://510kreport.com/device/K982965 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982965: Endocam Camera Systems 5502/5507 with CR Camera Heads and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982965

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026