510(k) Report

510(k) · Cleared

Cleared

Skytron Model 1100 and Model 142

K900290510(k) TraditionalCleared Feb 20, 199029-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

Skytron, Div. the Kmw Group, Inc. · JEA Table, Surgical With Orthopedic Accessories, Ac-Powered

Cleared on Feb 20, 1990 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 20, 1990
Review
29 days
Class
Class I
Product code
JEA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K900290Source: FDA 510(k) database · 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 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
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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?

No later submission names this one as a predicate yet.

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.

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—

More from Skytron, Div. the Kmw Group, Inc.

19 FDA decisions under this applicant name. See the company

  • K071698Aurora Led Series Surgical LightsSkytron, Div. the Kmw Group, Inc. · 20074 recalls
  • K021585Stellar Series Surgical Lights with HermesSkytron, Div. the Kmw Group, Inc. · 2002
  • K002463StellarSkytron, Div. the Kmw Group, Inc. · 2000
  • K992090Millennium GoldSkytron, Div. the Kmw Group, Inc. · 1999
  • K950192Skytron Skyboom SeriesSkytron, Div. the Kmw Group, Inc. · 19954 recalls

Recent decisions in JEA

The JEA category page

  • K953071Stryker COMMAND2 Office ConsoleStryker Instruments · 1995
  • K924094Mend ApcMend Technologies, Inc. · 1993
  • K910736Jackson Multipurpose Operating TableOrthopedic Systems, Inc. · 19911 recall
  • K911522Arthrobot (TM) Wrist Holder AccessoryAndronic Devices, Ltd. · 1991
  • K894789Dmi 250 Series Power Surgery TableM.D. Intl., Inc. · 1989

https://510kreport.com/device/K900290 · printed Nov 5, 2026

Cite this page

510(k) Report. “K900290: Skytron Model 1100 and Model 142.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K900290

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