510(k) Report

510(k) · Cleared

Cleared

Aesthesiometer

K874300510(k) TraditionalCleared Nov 6, 198717-day reviewClass I21 CFR 882.1200

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

Orthopedic Systems, Inc. · GWI Discriminator, Two-Point

Cleared on Nov 6, 1987 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 6, 1987
Review
17 days
Class
Class I
Product code
GWI
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K874300Source: FDA 510(k) database · 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.

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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All GWI devices

GWI Discriminator, Two-Point: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWI

FDA has decided no GWI device since 2007.

Median 510(k) review, days · GWI

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

Recalls per year · GWI

No recall names GWI since 2007.

Adverse event reports per year · GWI

No MAUDE report names GWI since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
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—

More from Orthopedic Systems, Inc.

95 FDA decisions under this applicant name. See the company

  • K952495Anchors Away Soft Tissue Attachment SystemOrthopedic Systems, Inc. · 1996
  • K920256Spine Motion Analyzer with EmgOrthopedic Systems, Inc. · 1992
  • K910736Jackson Multipurpose Operating TableOrthopedic Systems, Inc. · 19911 recall
  • K910031Park City Shoulder PositionerOrthopedic Systems, Inc. · 1991
  • K903938C Fit CupOrthopedic Systems, Inc. · 1991

Recent decisions in GWI

The GWI category page

  • K944234TCD or TCD Neuropathy StarJcm Management & Planning Co. · 1995

https://510kreport.com/device/K874300 · printed Nov 6, 2026

Cite this page

510(k) Report. “K874300: Aesthesiometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874300

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026