510(k) Report

510(k) · Cleared

Cleared

Countway Sys. Soiled Sponges-Blood Los

K830273510(k) TraditionalCleared Feb 28, 198334-day reviewClass I21 CFR 880.2740

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

Ritmed, Inc. · FQA Scale, Surgical Sponge

Cleared on Feb 28, 1983 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 28, 1983
Review
34 days
Class
Class I
Product code
FQA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K830273Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in FQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

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 FQA devices

FQA Scale, Surgical Sponge: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FQA

FDA has decided no FQA device since 2007.

Median 510(k) review, days · FQA

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

Recalls per year · FQA

No recall names FQA since 2007.

Adverse event reports per year · FQA

2in 2014

2013: 22014: 2
2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code FQA, 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—02
20140—02
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 Ritmed, Inc.

22 FDA decisions under this applicant name. See the company

  • K833626Floret Foam Prep SpongeRitmed, Inc. · 1984
  • K832874Isovis Wound ProtectorRitmed, Inc. · 1983
  • K830270Isovis Wound ProtectorRitmed, Inc. · 1983
  • K830261Floret Strung Gauze SpongesRitmed, Inc. · 1983
  • K830267Floret Special Gauze SpongesRitmed, Inc. · 1983

https://510kreport.com/device/K830273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830273: Countway Sys. Soiled Sponges-Blood Los.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830273

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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