510(k) Report

510(k) · Cleared

Cleared

Ksea SCB Acc Control

K023704510(k) TraditionalCleared Jan 30, 200387-day reviewClass II21 CFR 878.4580

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

KARL STORZ Endoscopy-America, Inc. · FTA Light, Surgical, Accessories

Cleared on Jan 30, 2003 after an 87-day review. The FDA summary names no predicate by number. 4 later devices descend from it.

Decided
Jan 30, 2003
Review
87 days
Class
Class II
Product code
FTA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 2 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared200020052010201520202025
  1. This deviceK023704 Ksea SCB Acc ControlKARL STORZ Endoscopy-America, Inc. · 2003
  2. Descendant · cites it directly · 3 of its ownK050829 Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005
  3. Descendant · 2 generations on · 2 of its ownK052740 Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005
  4. Descendant · 2 generations on · 1 of its ownK060717 Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006
  5. Descendant · 3 generations on · 0 of its ownK091648 Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis) · 2009

Most influential descendants

Showing 4 of 4 · See all
  • K050829Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005 · cites it directly3descendants
  • K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005 · 2 generations on2descendants
  • K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006 · 2 generations on1descendant
  • K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis) · 2009 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023704Ksea SCB Acc ControlKARL STORZ Endoscopy-America, Inc.2003—
+1K050829Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)2005—
+2K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)2005—
+2K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)2006—
+3K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis)2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200910
FIG. 1 — Lineage of K023704, 2003–2009Source: 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 FTA? 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?

The FDA summary names no predicate by number.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K050829Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20053

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, K050829 (Conmed Integrated Systems (Cmis), 2005) has gone furthest, with 3 descendants of its own.

How does its category compare?

All FTA devices

FTA Light, Surgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTA

1in 2015

2008: 12010: 12012: 12014: 32015: 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTA

61in 2014

2014: 61 days median
2007high 61 (2014)2026

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

Recalls per year · FTA

1in 2017

2007: 22017: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FTA

19in 2025

2009: 32013: 182014: 72015: 152016: 152017: 222018: 212019: 202020: 182021: 202022: 142023: 1052024: 292025: 19
2007high 105 (2023) · low 0 (2007)2025

MAUDE reports naming product code FTA, 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—20
20081—00
20090—03
20101—00
20110—00
20121—00
20130—018
201436107
20151—015
20160—015
20170—122
20180—021
20190—020
20200—018
20210—020
20220—014
20230—0105
20240—029
20250—019
20260—1—

What is it indicated for?

The KSEA SCB ACC Control provides remote control for overhead and surgical lights, cameras, video devices, telephones, air-conditioning and teleconference equipment in the operating room.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K023704: Ksea SCB Acc Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023704

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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