510(k) Report

510(k) · Cleared

Cleared

Spectrum DG-P7000 Pediatric Cradle

K933134510(k) TraditionalCleared Oct 7, 1993101-day reviewClass I21 CFR 892.1830

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

Spectrum X-Ray Corp. · KXH Cradle, Patient, Radiologic

Cleared on Oct 7, 1993 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 7, 1993
Review
101 days
Class
Class I
Product code
KXH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K933134Source: 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.

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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 KXH devices

KXH Cradle, Patient, Radiologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXH

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KXH

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

Recalls per year · KXH

No recall names KXH since 2007.

Adverse event reports per year · KXH

No MAUDE report names KXH since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20121—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Spectrum X-Ray Corp.

9 FDA decisions under this applicant name. See the company

  • K931563Spectrum Mark I Special Procedures TableSpectrum X-Ray Corp. · 1993
  • K870707Pentamax 1 Model B Table SystemSpectrum X-Ray Corp. · 1987
  • K834494Spectrum X-Ray CorpSpectrum X-Ray Corp. · 1984
  • K840463Digital CradleSpectrum X-Ray Corp. · 1984
  • K827450Simplamatic IiiSpectrum X-Ray Corp. · 1982

Recent decisions in KXH

The KXH category page

  • K122174Pediatric Positioner Pad SetGe Healthcare Coils (Usa Instruments, Inc.) · 2012
  • K953246OctorollOctostop, Inc. · 1995
  • K930124Variant of Octostop and OctopaqueOctostop, Inc. · 1994
  • K930357Accessory to Universal OctopaqueOctostop, Inc. · 1993
  • K884292Stretcher TableFischer Imaging Corp. · 1989

https://510kreport.com/device/K933134 · printed Nov 4, 2026

Cite this page

510(k) Report. “K933134: Spectrum DG-P7000 Pediatric Cradle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933134

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