510(k) Report

510(k) · Cleared

Recalled · 2009

Ferrozine (Colorimetric) Iron Binding Capacity

K864882510(k) TraditionalCleared Jan 21, 198740-day reviewClass I21 CFR 862.1410Recalls 8

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

Pointe Scientific, Inc., · JIY Photometric Method, Iron (Non-Heme)

Cleared on Jan 21, 1987 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 8 times.

Decided
Jan 21, 1987
Review
40 days
Class
Class I
Product code
JIY
Recalls
8
Predicates
0

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

FIG. 1 — Lineage of K864882Source: 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 JIY? 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
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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)

Recalls of this device

DateClassRecallRoot causeReason
Nov 16, 2009Not classifiedZ-0899-2010Device DesignTurbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009Not classifiedZ-0901-2010Device DesignTurbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009Not classifiedZ-0903-2010Device DesignTurbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009Not classifiedZ-0906-2010Device DesignTurbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009Not classifiedZ-0900-2010Device DesignTurbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009Not classifiedZ-0902-2010Device DesignTurbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009Not classifiedZ-0905-2010Device DesignTurbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009Not classifiedZ-0904-2010Device DesignTurbidity formation could occur, resulting in invalid test results being reported out.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JIY devices

JIY Photometric Method, Iron (Non-Heme): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIY

FDA has decided no JIY device since 2007.

Median 510(k) review, days · JIY

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

Recalls per year · JIY

1in 2025

2008: 12009: 82012: 12013: 12016: 32023: 22025: 1
2007high 8 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JIY

7in 2025

2012: 152013: 22016: 22017: 12020: 32021: 22022: 32023: 62024: 82025: 7
2007high 15 (2012) · low 0 (2007)2025

MAUDE reports naming product code JIY, 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—10
20090—80
20100—00
20110—00
20120—115
20130—12
20140—00
20150—00
20160—32
20170—01
20180—00
20190—00
20200—03
20210—02
20220—03
20230—26
20240—08
20250—17
20260—0—

More from Pointe Scientific, Inc.,

74 FDA decisions under this applicant name. See the company

  • K070757Microprotein Reagent SetPointe Scientific, Inc., · 2007
  • K062118Pointe 360Pointe Scientific, Inc., · 2007
  • K070251Carbon Dioxide Liquid Stable ReagentPointe Scientific, Inc., · 2007
  • K070207Multi-Analyte Chemistry CalibratorPointe Scientific, Inc., · 2007
  • K070504Ammonia/Alcohol Control SetPointe Scientific, Inc., · 2007

Recent decisions in JIY

The JIY category page

  • K061793Dimension Vista Iron Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 20061 recall
  • K060264Dimension Iron Flex Reagent Cartridge (Iron-DF85)Dade Behring, Inc. · 20062 recalls
  • K051115Sentinel Iron LiquidSentinel Ch. Srl · 2005
  • K033983Vitalab Iron ReagentClinical Data, Inc. · 2004
  • K030528Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 UG/DL)Clinical Data · 2003

https://510kreport.com/device/K864882 · printed Nov 6, 2026

Cite this page

510(k) Report. “K864882: Ferrozine (Colorimetric) Iron Binding Capacity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864882

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