510(k) Report

510(k) · Cleared

Cleared

Colorado Medical Model CTM-3000

K853735510(k) TraditionalCleared Oct 4, 198528-day reviewClass II21 CFR 876.5820

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

Colorado Medical, Inc. · FIZ Meter, Conductivity, Non-Remote

Cleared on Oct 4, 1985 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 4, 1985
Review
28 days
Class
Class II
Product code
FIZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K853735Source: 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.

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

Top candidate predicates for a new FIZ device

  1. #1 K201765 SmartHDM-510 Systemscore 0.3 · 2 generations · no Class I recall
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 FIZ devices

FIZ Meter, Conductivity, Non-Remote: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FIZ

1in 2020

2015: 12020: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FIZ

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

Recalls per year · FIZ

No recall names FIZ since 2007.

Adverse event reports per year · FIZ

No MAUDE report names FIZ since 2007.

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
20151—00
20160—00
20170—00
20180—00
20190—00
20201—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Colorado Medical, Inc.

6 FDA decisions under this applicant name. See the company

  • K870471Modified HR-3000 Reuse AdaptorColorado Medical, Inc. · 1987
  • K870689HR-3000 Reuse AdaptorColorado Medical, Inc. · 1987
  • K863471Colorado Medical Model PTC 1000Colorado Medical, Inc. · 1986
  • K841153Adaptor HR-3000 ReuseColorado Medical, Inc. · 1984
  • K830190Ahr-3000 RE-Use AdaptorColorado Medical, Inc. · 1983

Recent decisions in FIZ

The FIZ category page

  • K201765SmartHDM-510 SystemMesa Laboratories, Inc. · 2020
  • K150657Phoenix XL Dialysate MeterMesa Laboratories, Inc. · 2015
  • K05081290XL Instrumentation SystemMesa Laboratories, Inc. · 2005
  • K020909HDM99Ibp Instruments GmbH · 2002
  • K020908HDM97Ibp Instruments GmbH · 2002

https://510kreport.com/device/K853735 · printed Nov 4, 2026

Cite this page

510(k) Report. “K853735: Colorado Medical Model CTM-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853735

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