510(k) Report

510(k) · Cleared

Cleared

Cosmos

K870856510(k) TraditionalCleared Mar 30, 198727-day reviewClass I21 CFR 892.1770

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

Pausch Corp. · IYB Tube Mount, X-Ray, Diagnostic

Cleared on Mar 30, 1987 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 30, 1987
Review
27 days
Class
Class I
Product code
IYB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2008: 1 descendant cleared1990200020102020
  1. This deviceK870856 CosmosPausch Corp. · 1987
  2. Descendant · cites it directly · 1 of its ownK023008 Universal System, Model QV-800Quantum Medical Imaging, LLC · 2002
  3. Descendant · 2 generations on · 0 of its ownK083181 QV-9000 Universal SystemQuantum Medical Imaging, LLC · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K023008Universal System, Model QV-800Quantum Medical Imaging, LLC · 2002 · cites it directly1descendant
  • K083181QV-9000 Universal SystemQuantum Medical Imaging, LLC · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870856CosmosPausch Corp.1987—
+1K023008Universal System, Model QV-800Quantum Medical Imaging, LLC2002—
+2K083181QV-9000 Universal SystemQuantum Medical Imaging, LLC2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200810
FIG. 1 — Lineage of K870856, 1987–2008Source: FDA 510(k) summaries, read by 510(k) Report · 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 IYB? 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K023008Universal System, Model QV-800Quantum Medical Imaging, LLC20021

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, K023008 (Quantum Medical Imaging, LLC, 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All IYB devices

IYB Tube Mount, X-Ray, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYB

FDA has decided no IYB device since 2007.

Median 510(k) review, days · IYB

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

Recalls per year · IYB

1in 2025

2009: 12014: 12025: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · IYB

1in 2018

2007: 22008: 22009: 42010: 12012: 12013: 12015: 12018: 1
2007high 4 (2009) · low 0 (2011)2025

MAUDE reports naming product code IYB, 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—02
20080—02
20090—14
20100—01
20110—00
20120—01
20130—01
20140—10
20150—01
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—10
20260—0—

More from Pausch Corp.

8 FDA decisions under this applicant name. See the company

  • K973864Combi Elevator-2 & Combi Elevator-2 TomoPausch Corp. · 1998
  • K973834CS2000 & CS2000 TomoPausch Corp. · 1998
  • K903395Uromat 2000Pausch Corp. · 1990
  • K790740BS 66, Universal Bucky StandPausch Corp. · 1979
  • K790742KS-78 Vertical Wall Cassette HolderPausch Corp. · 1979

Recent decisions in IYB

The IYB category page

  • K935123Superstand 300Wuestec Medical, Inc. · 1996
  • K946261MTS-007, STS-008, Ssmts-010, Euro-40, 72, Super Euro 4072, 5000Scott Imaging Intl., Inc. · 1995
  • K941004CTS SystemAcoma Medical Imaging, Inc. · 1994
  • K941017F/C/W TubestandAcoma Medical Imaging, Inc. · 1994
  • K940442MPR-814Xri, Inc. · 1994

https://510kreport.com/device/K870856 · printed Nov 5, 2026

Cite this page

510(k) Report. “K870856: Cosmos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K870856

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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