510(k) Report

510(k) · Cleared

Cleared

Endomark Sterile India Ink

K042901510(k) TraditionalCleared Mar 16, 2005147-day reviewClass II21 CFR 876.1500

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

Pmt Corp. · NBG Marker, Colon

Cleared on Mar 16, 2005 as substantially equivalent to K993951 (Chek-Med Systems, 2000) after a 147-day review. Its family tree reaches back 1 generation to 2000.

Decided
Mar 16, 2005
Review
147 days
Class
Class II
Product code
NBG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K993951 (2000). No later device cites it as a predicate yet.

K993951 · Spot Endoscopic Marker · Chek-Med Systems · 20002000200220042006
K993951 · Spot Endoscopic Marker · Chek-Med Systems · 20000
  1. Root · 1 generation backK993951 Spot Endoscopic MarkerChek-Med Systems · 2000
  2. This deviceK042901 Endomark Sterile India InkPmt Corp. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993951Spot Endoscopic MarkerChek-Med Systems2000—
0 (this device)K042901Endomark Sterile India InkPmt Corp.2005—
FIG. 1 — Lineage of K042901, 2000–2005Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NBG? 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K993951Spot Endoscopic Marker
Summary page 1
…terile India Ink Common/Usual Name: Colon marker Classification Name: Colon marker 3. PREDICATE DEVICE Spot Endoscopic Marker (K993951) 4. DEVICE DESCRIPTION The EndomarkTM Sterile India Ink is a sterile, non-pyrogenic ink designed to be u…
Chek-Med Systems2000—

Also cleared against K993951: 1 other device →

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.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K993951.

How does its category compare?

All NBG devices

NBG Marker, Colon: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NBG

FDA has decided no NBG device since 2007.

Median 510(k) review, days · NBG

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

Recalls per year · NBG

No recall names NBG since 2007.

Adverse event reports per year · NBG

5in 2022

2022: 5
2007high 5 (2022) · low 0 (2007)2025

MAUDE reports naming product code NBG, 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—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—05
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The EndomarkTM Sterile India Ink is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will require surgical removal within thirty days.

Indications for use as stated in the FDA summary.

Also cleared against K993951

1 other device cites the same predicate.

  • K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm…Ninepoint Medical, Inc. · 2016

More from Pmt Corp.

20 FDA decisions under this applicant name. See the company

  • K122376PMT Truscan Surface ElectrodePmt Corp. · 2012
  • K090733PMT Halo SystemPmt Corp. · 2009
  • K082474PMT Subdural Cortical ElectrodesPmt Corp. · 2009
  • K033730PMT Sphenoidal Electrode and Accessory, Model 2101-31 and 2102-31 SeriesPmt Corp. · 2004
  • K972597PMT New Beginnings Gelshapes & AmendPmt Corp. · 1997

Recent decisions in NBG

The NBG category page

  • K993951Spot Endoscopic MarkerChek-Med Systems · 2000

https://510kreport.com/device/K042901 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042901: Endomark Sterile India Ink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042901

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026