510(k) Report

510(k) · Cleared

Cleared

Alginate Wool Fiber

K870383510(k) TraditionalCleared Apr 30, 198790-day reviewClass I21 CFR 872.6050

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

Adri · KHR Absorber, Saliva, Paper

Cleared on Apr 30, 1987 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 30, 1987
Review
90 days
Class
Class I
Product code
KHR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K870383Source: 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 KHR devices

KHR Absorber, Saliva, Paper: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KHR

FDA has decided no KHR device since 2007.

Median 510(k) review, days · KHR

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

Recalls per year · KHR

No recall names KHR since 2007.

Adverse event reports per year · KHR

1in 2019

2016: 12019: 1
2007high 1 (2016) · low 0 (2007)2025

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

More from Adri

6 FDA decisions under this applicant name. See the company

  • K041268Silversite or CalgitrolAdri · 2004
  • K011618Calgitrol AG Silver Alginate Wound DressingAdri · 2002
  • K000054Foam Calcium Alginate Topical Wound Dressing with CollagenAdri · 2000
  • K963656Foam Calcium Aliginate Topical Wound DressingAdri · 1996
  • K940404Alginate Fiber Topical Wound DressingAdri · 1994

Recent decisions in KHR

The KHR category page

  • K980783Simplex Saliva Absorber/Collector, Model Ssa-5Irt Management Corp. · 1998
  • K954068General Hygiene KitPhysician Industries, Inc. · 1995
  • K953812Gauze SpongeRemington Medical, Inc. · 1995
  • K891054Non-Sterile Gauze SpongeDispomed, Inc. · 1989
  • K891354Orthodontic Cotton Roll HoldersAmerican Orthodontics · 1989

https://510kreport.com/device/K870383 · printed Nov 4, 2026

Cite this page

510(k) Report. “K870383: Alginate Wool Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K870383

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