510(k) Report

510(k) · Cleared

Cleared

Safecrit Plastic Microhematocrit Tubes

K883185510(k) TraditionalCleared Aug 18, 198821-day reviewClass II21 CFR 864.6400

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

Norfolk Scientific, Inc. · GHY Hematocrit, Tube, Rack, Sealer, Holder

Cleared on Aug 18, 1988 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 18, 1988
Review
21 days
Class
Class II
Product code
GHY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K883185Source: 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 GHY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 GHY devices

GHY Hematocrit, Tube, Rack, Sealer, Holder: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GHY

FDA has decided no GHY device since 2007.

Median 510(k) review, days · GHY

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

Recalls per year · GHY

No recall names GHY since 2007.

Adverse event reports per year · GHY

No MAUDE report names GHY 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
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 Norfolk Scientific, Inc.

7 FDA decisions under this applicant name. See the company

  • K902028Statspin Illuminated Micro-Hematocrit Tube ReaderNorfolk Scientific, Inc. · 1990
  • K890669Statspin HDL-Cholesterol Precipitating Micro TubeNorfolk Scientific, Inc. · 1989
  • K881254Statspin Disposable Rotor, Product #RD01Norfolk Scientific, Inc. · 1988
  • K870511Chart-Type Micro Hematocrit Tube ReaderNorfolk Scientific, Inc. · 1987
  • K864974General Purpose CentrifugeNorfolk Scientific, Inc. · 1987

Recent decisions in GHY

The GHY category page

  • K881186Microhematocrit Tubes, Heparin & Microhema Tube,PLHelps Products, Inc. · 1988

https://510kreport.com/device/K883185 · printed Nov 5, 2026

Cite this page

510(k) Report. “K883185: Safecrit Plastic Microhematocrit Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K883185

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