510(k) Report

510(k) · Cleared

Cleared

Florio CPC Band

K760970510(k) TraditionalCleared Nov 23, 197619-day reviewClass I21 CFR 888.4540

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

Richard'S Medical Equip., Inc. · HWN Instrument, Compression

Cleared on Nov 23, 1976 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 23, 1976
Review
19 days
Class
Class I
Product code
HWN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K760970Source: 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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  • 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?

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 HWN devices

HWN Instrument, Compression: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWN

FDA has decided no HWN device since 2007.

Median 510(k) review, days · HWN

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

Recalls per year · HWN

9in 2010

2010: 9
2007high 9 (2010) · low 0 (2007)2026

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

Adverse event reports per year · HWN

179in 2025

2008: 12009: 32011: 72012: 52013: 362014: 212015: 82016: 162017: 292018: 212019: 372020: 512021: 882022: 642023: 822024: 832025: 179
2007high 179 (2025) · low 0 (2007)2025

MAUDE reports naming product code HWN, 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—01
20090—03
20100—90
20110—07
20120—05
20130—036
20140—021
20150—08
20160—016
20170—029
20180—021
20190—037
20200—051
20210—088
20220—064
20230—082
20240—083
20250—0179
20260—0—

More from Richard'S Medical Equip., Inc.

48 FDA decisions under this applicant name. See the company

  • K830793Patient Guided Elbow & Shoulder ExercRichard'S Medical Equip., Inc. · 1983
  • K823837RMC Total Knee SystemRichard'S Medical Equip., Inc. · 1983
  • K823726Spectron Conversion Endoprosthesis CupRichard'S Medical Equip., Inc. · 1983
  • K823724Spectron Neck Replacement ProsthesisRichard'S Medical Equip., Inc. · 1983
  • K823723Spectron Proximal Femoral ProsthesisRichard'S Medical Equip., Inc. · 1983

Recent decisions in HWN

The HWN category page

  • K854241Aot External Compress DeviceAdvanced Ortho-Technology, Inc. · 1986
  • K792253Ariculated Tension Device Synthes TenSynthes (Usa) · 1979
  • K770349Rigid Teaching AttachmentRichard Wolf Medical Instruments Corp. · 1977

https://510kreport.com/device/K760970 · printed Nov 4, 2026

Cite this page

510(k) Report. “K760970: Florio CPC Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K760970

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