510(k) Report

510(k) · Cleared

Recalled · 2011

Jackson Multipurpose Operating Table

K910736510(k) TraditionalCleared May 21, 199189-day reviewClass I21 CFR 878.4960Recalls 1

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

Orthopedic Systems, Inc. · JEA Table, Surgical With Orthopedic Accessories, Ac-Powered

Cleared on May 21, 1991 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided
May 21, 1991
Review
89 days
Class
Class I
Product code
JEA
Recalls
1
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K910736Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 JEA? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 29, 2011Not classifiedZ-0073-2012Use errorReports of injury related incidents while using the Mizuho OSI Modular Table System.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JEA devices

JEA Table, Surgical With Orthopedic Accessories, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEA

FDA has decided no JEA device since 2007.

Median 510(k) review, days · JEA

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

Recalls per year · JEA

8in 2024

2007: 12010: 12011: 12012: 12013: 12014: 132016: 62019: 12024: 8
2007high 13 (2014) · low 0 (2008)2026

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

Adverse event reports per year · JEA

27in 2025

2007: 52008: 82009: 102010: 92011: 252012: 202013: 222014: 412015: 262016: 352017: 442018: 602019: 632020: 462021: 402022: 322023: 332024: 362025: 27
2007high 63 (2019) · low 5 (2007)2025

MAUDE reports naming product code JEA, 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—15
20080—08
20090—010
20100—19
20110—125
20120—120
20130—122
20140—1341
20150—026
20160—635
20170—044
20180—060
20190—163
20200—046
20210—040
20220—032
20230—033
20240—836
20250—027
20260—0—
Cite this page

510(k) Report. “K910736: Jackson Multipurpose Operating Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910736

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026