510(k) Report

510(k) · Cleared

Cleared

Digit-Grip with LCD (DGR002)

K970870510(k) TraditionalCleared May 2, 199753-day reviewClass I21 CFR 888.1250

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

Nk Biotechnical Corp. · HRW Dynamometer, Nonpowered

Cleared on May 2, 1997 after a 53-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 2, 1997
Review
53 days
Class
Class I
Product code
HRW
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K970870Source: 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 lists a 510(k) statement for it but has not posted the file, 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 HRW devices

HRW Dynamometer, Nonpowered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRW

FDA has decided no HRW device since 2007.

Median 510(k) review, days · HRW

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

Recalls per year · HRW

No recall names HRW since 2007.

Adverse event reports per year · HRW

1in 2020

2010: 12020: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code HRW, 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—00
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Nk Biotechnical Corp.

2 FDA decisions under this applicant name. See the company

  • K981730Digit-Grip with LCD, Model Number DGR 002Nk Biotechnical Corp. · 1998

Recent decisions in HRW

The HRW category page

  • K971407Jtech Commander and AlgometerJ-Tech Medical, Inc. · 1998
  • K894557Lightscope SetOptik · 1989
  • K861396Handheld Dynamometer, Model #160 and #111Spark Instruments & Academics, Inc. · 1986
  • K821631Pinch Gauge, 0-301 LBS.Fred Sammons, Inc. · 1982
  • K812343Pinch MeterFred Sammons, Inc. · 1981

https://510kreport.com/device/K970870 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970870: Digit-Grip with LCD (DGR002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970870

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