510(k) Report

510(k) · Cleared

Cleared

Hemaflour ZP

K760506510(k) TraditionalCleared Oct 28, 197666-day reviewClass I21 CFR 862.2560

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

Buchler Instruments, Inc. · KHO Fluorometer, For Clinical Use

Cleared on Oct 28, 1976 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 28, 1976
Review
66 days
Class
Class I
Product code
KHO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K760506Source: 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 KHO? 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KHO devices

KHO Fluorometer, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KHO

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KHO

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

Recalls per year · KHO

7in 2018

2011: 22012: 12014: 22017: 42018: 7
2007high 7 (2018) · low 0 (2007)2026

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

Adverse event reports per year · KHO

178in 2025

2007: 52008: 12009: 242010: 492011: 292012: 682013: 532014: 652015: 302016: 352017: 1522018: 2,1232019: 4402020: 2572021: 2132022: 2242023: 2602024: 1682025: 178
2007high 2,123 (2018) · low 1 (2008)2025

MAUDE reports naming product code KHO, 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—05
20080—01
20090—024
20100—049
20110—229
20121—168
20130—053
20140—265
20150—030
20160—035
20170—4152
20180—72,123
20190—0440
20200—0257
20210—0213
20220—0224
20230—0260
20240—0168
20250—0178
20260—0—

More from Buchler Instruments, Inc.

2 FDA decisions under this applicant name. See the company

  • K791312Catalog #4-2520 Chloridometer ChlorideBuchler Instruments, Inc. · 1979

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https://510kreport.com/device/K760506 · printed Nov 6, 2026

Cite this page

510(k) Report. “K760506: Hemaflour ZP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760506

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