510(k) Report

510(k) · Cleared

Cleared

Biodex,Model B-2000

K913021510(k) TraditionalCleared Oct 3, 199186-day reviewClass II21 CFR 890.1925

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

Biodex Corp. · IKK System, Isokinetic Testing And Evaluation

Cleared on Oct 3, 1991 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Oct 3, 1991
Review
86 days
Class
Class II
Product code
IKK
Recalls
None
Predicates
0

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

Descendants, by year cleared 1995: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK913021 Biodex,Model B-2000Biodex Corp. · 1991
  2. Descendant · cites it directly · 1 of its ownK951770 Biodex System 3 Model S3S-AP and Model S3D-3APBiodex Medical Systems, Inc. · 1995
  3. Descendant · 2 generations on · 0 of its ownK123746 Ames Therapy DeviceAmes Technology, Inc. · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K951770Biodex System 3 Model S3S-AP and Model S3D-3APBiodex Medical Systems, Inc. · 1995 · cites it directly1descendant
  • K123746Ames Therapy DeviceAmes Technology, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913021Biodex,Model B-2000Biodex Corp.1991—
+1K951770Biodex System 3 Model S3S-AP and Model S3D-3APBiodex Medical Systems, Inc.1995—
+2K123746Ames Therapy DeviceAmes Technology, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199510
201310
FIG. 1 — Lineage of K913021, 1991–2013Source: 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 IKK? 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K951770Biodex System 3 Model S3S-AP and Model S3D-3APBiodex Medical Systems, Inc.19951

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, K951770 (Biodex Medical Systems, Inc., 1995) has gone furthest, with 1 descendant of its own.

How does its category compare?

All IKK devices

IKK System, Isokinetic Testing And Evaluation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IKK

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IKK

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

Recalls per year · IKK

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · IKK

2in 2024

2009: 22011: 12012: 12013: 32014: 22016: 72017: 22019: 22020: 12021: 12022: 32023: 42024: 2
2007high 7 (2016) · low 0 (2007)2025

MAUDE reports naming product code IKK, 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—02
20100—00
20110—01
20120—11
20131—13
20140—02
20150—00
20160—07
20170—02
20180—00
20190—02
20200—01
20210—01
20220—03
20230—04
20240—02
20250—00
20260—0—

More from Biodex Corp.

7 FDA decisions under this applicant name. See the company

  • K915846Biodex System 2 AutoprogramBiodex Corp. · 1992
  • K915648Biodex System 2 AutoprogramBiodex Corp. · 1992
  • K913020Biodex System 2,Model S2-SBiodex Corp. · 1991
  • K900450Biodex Lift SimulatorBiodex Corp. · 1990
  • K900741Biodex Back System AttachmentBiodex Corp. · 1990

Recent decisions in IKK

The IKK category page

  • K123746Ames Therapy DeviceAmes Technology, Inc. · 2013
  • K952090Humac SystemComputer Sports Medicine, Inc. · 1995
  • K951770Biodex System 3 Model S3S-AP and Model S3D-3APBiodex Medical Systems, Inc. · 1995
  • K951916CC Rider, Model ME180Mettler Electronics Corp. · 1995
  • K950095CYBEX 770Cybex · 1995

https://510kreport.com/device/K913021 · printed Nov 4, 2026

Cite this page

510(k) Report. “K913021: Biodex,Model B-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913021

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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