510(k) Report

510(k) · Cleared

Cleared

Zinetics (R) Emc

K884527510(k) TraditionalCleared Feb 28, 1989124-day reviewClass II21 CFR 876.1725

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

Zinetics Medical, Inc. · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube

Cleared on Feb 28, 1989 after a 124-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
Feb 28, 1989
Review
124 days
Class
Class II
Product code
KLA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2007: 1 descendant cleared1990200020102020
  1. This deviceK884527 Zinetics (R) EmcZinetics Medical, Inc. · 1989
  2. Descendant · cites it directly · 1 of its ownK032138 Medtronic Single Use Esophageal Manometric Catheter, Medtronic…Medtronic Vascular · 2003
  3. Descendant · 2 generations on · 0 of its ownK062362 Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal…Sarmed Srl · 2007

Most influential descendants

Showing 2 of 2 · See all
  • K032138Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal…Medtronic Vascular · 2003 · cites it directly1descendant
  • K062362Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry CathetersSarmed Srl · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K884527Zinetics (R) EmcZinetics Medical, Inc.1989—
+1K032138Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use…Medtronic Vascular2003—
+2K062362Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry…Sarmed Srl2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
FIG. 1 — Lineage of K884527, 1989–2007Source: FDA 510(k) summaries, read by 510(k) Report · 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 KLA? 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 KLA device

  1. #1 K242666 Fecobionics Anorectal Systemscore 10.3 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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? (2)

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

NumberDeviceApplicantDecidedDescendants
K032138Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal…Medtronic Vascular20031

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, K032138 (Medtronic Vascular, 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KLA devices

KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLA

1in 2025

2007: 12012: 12015: 12017: 12018: 12024: 22025: 1
2007high 2 (2024) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLA

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

Recalls per year · KLA

No recall names KLA since 2007.

Adverse event reports per year · KLA

1in 2024

2015: 12017: 12018: 12020: 12023: 22024: 1
2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code KLA, 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
20071—00
20080—00
20090—00
20100—00
20110—00
20121—00
20130—00
20140—00
20151—01
20160—00
20171—01
20181—01
20190—00
20200—01
20210—00
20220—00
20230—02
20242—01
20251—00
20260—0—

More from Zinetics Medical, Inc.

4 FDA decisions under this applicant name. See the company

  • K921682Zinetics AmcZinetics Medical, Inc. · 1994
  • K910694Zinetics Internal Reference ProbeZinetics Medical, Inc. · 1991
  • K883319Hill Nasogastric TubeZinetics Medical, Inc. · 1988

Recent decisions in KLA

The KLA category page

  • K242666Fecobionics Anorectal SystemGi Bionics, LLC · 2025
  • K242304REDNeuraxis, Inc. · 2024
  • K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp. · 2024
  • K180135THD Anopress with THD SensyProbeThd Spa · 2018
  • K161785THD AnopressThd Spa · 2017

https://510kreport.com/device/K884527 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884527: Zinetics (R) Emc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884527

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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