510(k) Report

510(k) · Cleared

Cleared

Satoban First Aid Tape

K823076510(k) TraditionalCleared Jan 12, 198385-day reviewClass I21 CFR 880.5240

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

Food and Drug Service, Inc. · KGX Tape And Bandage, Adhesive

Cleared on Jan 12, 1983 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 12, 1983
Review
85 days
Class
Class I
Product code
KGX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K823076Source: 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 KGX devices

KGX Tape And Bandage, Adhesive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGX

FDA has decided no KGX device since 2007.

Median 510(k) review, days · KGX

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

Recalls per year · KGX

8in 2025

2010: 82011: 42012: 22015: 32019: 12025: 8
2007high 8 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KGX

317in 2025

2007: 372008: 262009: 372010: 312011: 392012: 592013: 882014: 982015: 2002016: 1582017: 2062018: 2132019: 4882020: 1,2902021: 5622022: 2532023: 1922024: 2242025: 317
2007high 1,290 (2020) · low 26 (2008)2025

MAUDE reports naming product code KGX, 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—037
20080—026
20090—037
20100—831
20110—439
20120—259
20130—088
20140—098
20150—3200
20160—0158
20170—0206
20180—0213
20190—1488
20200—01,290
20210—0562
20220—0253
20230—0192
20240—0224
20250—8317
20260—0—

More from Food and Drug Service, Inc.

2 FDA decisions under this applicant name. See the company

  • K831706Sato Family First Aid KitFood and Drug Service, Inc. · 1983

Recent decisions in KGX

The KGX category page

  • K001240Seragard Injection PatchPlatinum Services, Inc. · 2000
  • K983368Care Band Antibacterial BandagesAso Corp. · 1999
  • K972914Syvek PatchMarine Polymer Technologies, Inc. · 1997
  • K943314Adhesive Bandages with Otc DrugJohnson & Johnson Consumer Products, Inc. · 1996
  • K952606Targett PatchCutting Edge Technologies, Inc. · 1995

https://510kreport.com/device/K823076 · printed Nov 4, 2026

Cite this page

510(k) Report. “K823076: Satoban First Aid Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K823076

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