510(k) Report

510(k) · Cleared

Cleared

Ralco Collimator, Automatic Radiographic

K820306510(k) TraditionalCleared Mar 5, 198229-day reviewClass II21 CFR 892.1610

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

Tecnomed, Inc. · KPW Device, Beam Limiting, X-Ray, Diagnostic

Cleared on Mar 5, 1982 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Mar 5, 1982
Review
29 days
Class
Class II
Product code
KPW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared19801990200020102020
  1. This deviceK820306 Ralco Collimator, Automatic RadiographicTecnomed, Inc. · 1982
  2. Descendant · cites it directly · 2 of its ownK072780 Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L. · 2007
  3. Descendant · 2 generations on · 0 of its ownK091517 Ralco, Model R225 AcsRalco S.R.L. · 2009
  4. Descendant · 2 generations on · 0 of its ownK083029 Model R605DASM Automatic X-Ray CollimatorRalco S.R.L. · 2008

Most influential descendants

Showing 3 of 3 · See all
  • K072780Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L. · 2007 · cites it directly2descendants
  • K091517Ralco, Model R225 AcsRalco S.R.L. · 2009 · 2 generations on0descendants
  • K083029Model R605DASM Automatic X-Ray CollimatorRalco S.R.L. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K820306Ralco Collimator, Automatic RadiographicTecnomed, Inc.1982—
+1K072780Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L.2007—
+2K091517Ralco, Model R225 AcsRalco S.R.L.2009—
+2K083029Model R605DASM Automatic X-Ray CollimatorRalco S.R.L.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
FIG. 1 — Lineage of K820306, 1982–2009Source: 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 KPW? 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K072780Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L.20072

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, K072780 (Ralco S.R.L., 2007) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KPW devices

KPW Device, Beam Limiting, X-Ray, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPW

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPW

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

Recalls per year · KPW

No recall names KPW since 2007.

Adverse event reports per year · KPW

1in 2014

2007: 12014: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code KPW, 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—01
20080—00
20090—00
20101—00
20110—00
20120—00
20130—00
20140—01
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 Tecnomed, Inc.

18 FDA decisions under this applicant name. See the company

  • K892226Tec 6340 90/15 Radiographic/Fluoroscopic TableTecnomed, Inc. · 1989
  • K854203Tec 2720 Mamex DC MagTecnomed, Inc. · 1986
  • K820307Tecnomed Generator, Radiograph., 3 PhaseTecnomed, Inc. · 1982
  • K827124Ralco Collimator, Automatic, RadiographicTecnomed, Inc. · 1982
  • K827126Technomed Generator, Radiographic, 3 PhaseTecnomed, Inc. · 1982

Recent decisions in KPW

The KPW category page

  • K093596Lumos, Model R 72BLumos, Inc. · 2010
  • K062788Collimator, Model M-38Umi International · 2006
  • K030487R 72Ralco S.R.L. · 2003
  • K954310BLA-800AToshiba Medical Systems · 1995
  • K946320R 302Ralco S.R.L. · 1995

https://510kreport.com/device/K820306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K820306: Ralco Collimator, Automatic Radiographic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820306

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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