510(k) Report

510(k) · Cleared

Cleared

Fulcrum

K021949510(k) TraditionalCleared Aug 12, 200260-day reviewClass II21 CFR 892.2030

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

Howtek, Inc. · LMA Digitizer, Image, Radiological

Cleared on Aug 12, 2002 after a 60-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided
Aug 12, 2002
Review
60 days
Class
Class II
Product code
LMA
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared200020052010201520202025
  1. This deviceK021949 FulcrumHowtek, Inc. · 2002
  2. Descendant · cites it directly · 0 of its ownK091288 Medi-6000 Medical Image DigitizerMicrotek International, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K091288Medi-6000 Medical Image DigitizerMicrotek International, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021949FulcrumHowtek, Inc.2002—
+1K091288Medi-6000 Medical Image DigitizerMicrotek International, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K021949, 2002–2009Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LMA? 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Howtek MultiRAD
Named without a submission number
—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K091288Medi-6000 Medical Image DigitizerMicrotek International, Inc.20090

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, K091288 (Microtek International, Inc., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LMA devices

LMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMA

3in 2013

2009: 12010: 22013: 3
2007high 3 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMA

80in 2013

2013: 80 days median
2007high 80 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LMA

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · LMA

1in 2013

2008: 32012: 12013: 1
2007high 3 (2008) · low 0 (2007)2025

MAUDE reports naming product code LMA, 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—03
20091—00
20102—00
20110—00
20120—01
201338001
20140—00
20150—00
20160—00
20170—00
20180—00
20190—10
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Howtek Fulcrum Family consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Fulcrum is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications.

The Fulcrum Family does not include applications specific software (Picture Archiving and Communications (PAC) system, Teleradiology, or Computer Aided Detection (CAD) software). The manufacturer of the application software will determine specific indications for use. These third-party software packages or complete PAC systems are approved separately.

Indications for use as stated in the FDA summary.

More from Howtek, Inc.

5 FDA decisions under this applicant name. See the company

  • K973081Digitizer Director: Image Compression Module (HO4059-Rev 2.0)Howtek, Inc. · 1997
  • K972191Digitizer Director (HSC025-01)Howtek, Inc. · 1997
  • K970908Howtek 960Howtek, Inc. · 1997
  • K953117Scanmaster DXHowtek, Inc. · 1996

Recent decisions in LMA

The LMA category page

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https://510kreport.com/device/K021949 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021949: Fulcrum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021949

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026