510(k) Report

510(k) · Cleared

Cleared

Multi-AD Fluid Dispensing Pump MP-3000

K801008510(k) TraditionalCleared Jun 2, 198035-day reviewClass I21 CFR 880.6430

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

Burron Medical Products, Inc. · KYX Dispenser, Liquid Medication

Cleared on Jun 2, 1980 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jun 2, 1980
Review
35 days
Class
Class I
Product code
KYX
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2015: 1 descendant cleared19801990200020102020
  1. This deviceK801008 Multi-AD Fluid Dispensing Pump MP-3000Burron Medical Products, Inc. · 1980
  2. Descendant · cites it directly · 1 of its ownK980109 Cyclotech Cyclosporine Oral Solutions DispenserSangstat Medical Corp. · 1998
  3. Descendant · 2 generations on · 0 of its ownK143177 KleenGel DispenserKleengel, LLC · 2015

Most influential descendants

Showing 2 of 2 · See all
  • K980109Cyclotech Cyclosporine Oral Solutions DispenserSangstat Medical Corp. · 1998 · cites it directly1descendant
  • K143177KleenGel DispenserKleengel, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K801008Multi-AD Fluid Dispensing Pump MP-3000Burron Medical Products, Inc.1980—
+1K980109Cyclotech Cyclosporine Oral Solutions DispenserSangstat Medical Corp.1998—
+2K143177KleenGel DispenserKleengel, LLC2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
201510
FIG. 1 — Lineage of K801008, 1980–2015Source: FDA 510(k) summaries, read by 510(k) Report · 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 KYX? 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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980109Cyclotech Cyclosporine Oral Solutions DispenserSangstat Medical Corp.19981

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.

What does this lineage say?

  • Of its descendants, K980109 (Sangstat Medical Corp., 1998) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KYX devices

KYX Dispenser, Liquid Medication: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYX

1in 2015

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

2026 to Oct 25, outlined.

Median 510(k) review, days · KYX

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

Recalls per year · KYX

1in 2022

2011: 22014: 12022: 1
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · KYX

11in 2025

2007: 32008: 42009: 72010: 62011: 52012: 62013: 42014: 12015: 112016: 92017: 172018: 172019: 172020: 332021: 72022: 112023: 312024: 202025: 11
2007high 33 (2020) · low 1 (2014)2025

MAUDE reports naming product code KYX, 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—03
20080—04
20090—07
20100—06
20110—25
20120—06
20130—04
20140—11
20151—011
20160—09
20170—017
20180—017
20190—017
20200—033
20210—07
20220—111
20230—031
20240—020
20250—011
20260—0—

More from Burron Medical Products, Inc.

41 FDA decisions under this applicant name. See the company

  • K870403Cavafix (R) Central Venous Catheter Kit W/SutureBurron Medical Products, Inc. · 1987
  • K862412IntestoplantBurron Medical Products, Inc. · 1986
  • K861479Cavafix, Central Venous Catheter KitBurron Medical Products, Inc. · 1986
  • K860126Stimuplex, Nerve StimulatorBurron Medical Products, Inc. · 19864 recalls
  • K851293ImplantofixBurron Medical Products, Inc. · 1986

Recent decisions in KYX

The KYX category page

  • K143177KleenGel DispenserKleengel, LLC · 2015
  • K980109Cyclotech Cyclosporine Oral Solutions DispenserSangstat Medical Corp. · 1998
  • K954181Canyons BI-Directional Check ValveCanyon Medical Products · 1995
  • K830571Bottle AdapterBurron Medical Products, Inc. · 1983
  • K800437Syringe Tip ConnectorBurron Medical Products, Inc. · 1980

https://510kreport.com/device/K801008 · printed Nov 6, 2026

Cite this page

510(k) Report. “K801008: Multi-AD Fluid Dispensing Pump MP-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K801008

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