510(k) Report

510(k) · Cleared

Cleared

Model 410 Dental X-Ray Film Processors

K874118510(k) TraditionalCleared Nov 6, 198728-day reviewClass II21 CFR 892.1900

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

Dent-X Co. · EGY Processor, Radiographic-Film, Automatic, Dental

Cleared on Nov 6, 1987 after a 28-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
Nov 6, 1987
Review
28 days
Class
Class II
Product code
EGY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2011: 1 descendant cleared2010: 1 descendant cleared1990200020102020
  1. This deviceK874118 Model 410 Dental X-Ray Film ProcessorsDent-X Co. · 1987
  2. Descendant · cites it directly · 1 of its ownK093503 Intrax Film ProcessorVelopex International, Inc. · 2010
  3. Descendant · cites it directly · 0 of its ownK111167 Xtender Film Processor, Sprint Film Processor Model Xtender Model…Velopex International, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K093503Intrax Film ProcessorVelopex International, Inc. · 2010 · cites it directly1descendant
  • K111167Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintVelopex International, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874118Model 410 Dental X-Ray Film ProcessorsDent-X Co.1987—
+1K093503Intrax Film ProcessorVelopex International, Inc.2010—
+1K111167Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintVelopex International, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
FIG. 1 — Lineage of K874118, 1987–2011Source: 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 EGY? 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)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093503Intrax Film ProcessorVelopex International, Inc.20101
K111167Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintVelopex International, Inc.20110

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, K093503 (Velopex International, Inc., 2010) has gone furthest, with 1 descendant of its own.

How does its category compare?

All EGY devices

EGY Processor, Radiographic-Film, Automatic, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EGY

FDA has decided no EGY device since 2007.

Median 510(k) review, days · EGY

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

Recalls per year · EGY

No recall names EGY since 2007.

Adverse event reports per year · EGY

1in 2012

2007: 22009: 12010: 12012: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code EGY, 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—00
20090—01
20100—01
20110—00
20120—01
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—

Recent decisions in EGY

The EGY category page

  • K992896DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)Dental X-Ray Support Systems, Inc. · 1999
  • K955825Smith S-100 Time & Temperature ControlSmith Companies Dental Products · 1996
  • K955643Alara Imaging SystemDenoptix, Inc. · 1996
  • K945682Processor, Radiographic-Film, Automatic, DentalGendex Corp. · 1995
  • K900156AP201 Dental X-Ray Film ProcessorAllied Photo Products Co., Inc. · 1990

https://510kreport.com/device/K874118 · printed Nov 6, 2026

Cite this page

510(k) Report. “K874118: Model 410 Dental X-Ray Film Processors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874118

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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