510(k) Report

510(k) · Cleared

Cleared

Patpos Compact

K930295510(k) TraditionalCleared May 21, 1993120-day reviewClass I21 CFR 892.5780

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

Cp Bio-Medical Corp. · IWE Monitor, Patient Position, Light-Beam

Cleared on May 21, 1993 after a 120-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.

Decided
May 21, 1993
Review
120 days
Class
Class I
Product code
IWE
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared2005: 2 descendants cleared2003: 1 descendant cleared2004: 1 descendant cleared2012: 2 descendants cleared2008: 1 descendant cleared2013: 1 descendant cleared2014: 2 descendants cleared1990200020102020
  1. This deviceK930295 Patpos CompactCp Bio-Medical Corp. · 1993
  2. Descendant · cites it directly · 10 of its ownK981424 Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998
  3. Descendant · 2 generations on · 4 of its ownK032100 I-BEAMComputerized Medical Systems, Inc. · 2003
  4. Descendant · 2 generations on · 3 of its ownK042110 BeamcathBeampoint AB · 2005
  5. Descendant · 2 generations on · 3 of its ownK041937 RestituResonant Medical, Inc. · 2004
  6. Descendant · 3 generations on · 2 of its ownK111332 Clarity Obp SystemElekta, Ltd. · 2012

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1998: 12003: 12004: 12005: 22008: 12012: 22013: 12014: 2
1998high 2 (2005) · low 0 (1999)2026

Most influential descendants

Showing 5 of 11 · See all
  • K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998 · cites it directly10descendants
  • K032100I-BEAMComputerized Medical Systems, Inc. · 2003 · 2 generations on4descendants
  • K042110BeamcathBeampoint AB · 2005 · 2 generations on3descendants
  • K041937RestituResonant Medical, Inc. · 2004 · 2 generations on3descendants
  • K111332Clarity Obp SystemElekta, Ltd. · 2012 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930295Patpos CompactCp Bio-Medical Corp.1993—
+1K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp.1998—
+2K032100I-BEAMComputerized Medical Systems, Inc.2003—
+2K042110BeamcathBeampoint AB2005—
+2K041937RestituResonant Medical, Inc.2004—
+3K111332Clarity Obp SystemElekta, Ltd.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200310
200410
200520
200810
201220
201310
201420
FIG. 1 — Lineage of K930295, 1993–2014Source: 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.

Planning a device in IWE? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp.199810

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, K981424 (Nomos Corp., 1998) has gone furthest, with 10 descendants of its own.

How does its category compare?

All IWE devices

IWE Monitor, Patient Position, Light-Beam: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IWE

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IWE

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

Recalls per year · IWE

1in 2025

2009: 12011: 22023: 22025: 1
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · IWE

1in 2018

2009: 12015: 12018: 1
2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code IWE, 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—00
20080—00
20090—11
20100—00
20110—20
20120—00
20130—00
20140—00
20151—01
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—20
20240—00
20250—10
20260—0—

More from Cp Bio-Medical Corp.

3 FDA decisions under this applicant name. See the company

  • K930294Patpos GreenCp Bio-Medical Corp. · 1993
  • K930296Patpos RedCp Bio-Medical Corp. · 1993

Recent decisions in IWE

The IWE category page

  • K152303CT Sim Laser SystemGammex, Inc. · 2015
  • K973162Dual Radiation Targeting System DRTS DrapeHogan & Hartson · 1997
  • K955236Green Tec-2100Medtec, Inc. · 1996
  • K954414Centralite BackpointerDiacor, Inc. · 1995
  • K950293Tec-2110 Green Laser Model MT-HNGMedtec, Inc. · 1995

https://510kreport.com/device/K930295 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930295: Patpos Compact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930295

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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