510(k) Report

510(k) · Cleared

Cleared

Oper. Table for Percutan. Trans. Coronary Angio.

K883613510(k) TraditionalCleared Sep 15, 198824-day reviewClass I21 CFR 878.4960

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

Stierlen-Maquet AG · GDC Table, Operating-Room, Electrical

Cleared on Sep 15, 1988 after a 24-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
Sep 15, 1988
Review
24 days
Class
Class I
Product code
GDC
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared1990200020102020
  1. This deviceK883613 Oper. Table for Percutan. Trans. Coronary Angio.Stierlen-Maquet AG · 1988
  2. Descendant · cites it directly · 0 of its ownK993947 Koordinant Angiographic and Operating Room Model X-Ray Table FamilySiemens Corp. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K993947Koordinant Angiographic and Operating Room Model X-Ray Table FamilySiemens Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K883613Oper. Table for Percutan. Trans. Coronary Angio.Stierlen-Maquet AG1988—
+1K993947Koordinant Angiographic and Operating Room Model X-Ray Table FamilySiemens Corp.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K883613, 1988–1999Source: 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.

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  • 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K993947Koordinant Angiographic and Operating Room Model X-Ray Table FamilySiemens Corp.19990

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, K993947 (Siemens Corp., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GDC devices

GDC Table, Operating-Room, Electrical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDC

FDA has decided no GDC device since 2007.

Median 510(k) review, days · GDC

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

Recalls per year · GDC

1in 2024

2007: 12009: 22014: 12015: 12019: 22022: 62024: 12026 (partial year): 1
2007high 6 (2022) · low 0 (2008)2026

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

Adverse event reports per year · GDC

101in 2025

2008: 82009: 52010: 342011: 332012: 332013: 392014: 1052015: 1022016: 1402017: 802018: 522019: 642020: 2532021: 2592022: 572023: 622024: 912025: 101
2007high 259 (2021) · low 0 (2007)2025

MAUDE reports naming product code GDC, 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—10
20080—08
20090—25
20100—034
20110—033
20120—033
20130—039
20140—1105
20150—1102
20160—0140
20170—080
20180—052
20190—264
20200—0253
20210—0259
20220—657
20230—062
20240—191
20250—0101
20260—1—

More from Stierlen-Maquet AG

10 FDA decisions under this applicant name. See the company

  • K970807Mobile Operating Table 1132.01Stierlen-Maquet AG · 1997
  • K926525Betastar 1131.02 Mobile Operating TableStierlen-Maquet AG · 1993
  • K920890Operating Table System-Betamaquet 1140Stierlen-Maquet AG · 1992
  • K873276Extension Device 1416Stierlen-Maquet AG · 1987
  • K873275Extension Table 1417Stierlen-Maquet AG · 1987

Recent decisions in GDC

The GDC category page

  • K971390Quantum 3080SP Surgical TableSTERIS Corporation · 1997
  • K970807Mobile Operating Table 1132.01Stierlen-Maquet AG · 1997
  • K964273Dura-Board ArmboardAllen Medical Systems, Inc. · 1997
  • K940616Skytron Elite 3500 TableSkytron, Div. the Kmw Group, Inc. · 1994
  • K934744Midmark Magnum General Surgical TableMidmark Corp. · 1994

https://510kreport.com/device/K883613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K883613: Oper. Table for Percutan. Trans. Coronary Angio..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883613

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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