510(k) Report

510(k) · Cleared

Cleared

Sil-Med T-Tube Drain

K903989510(k) TraditionalCleared Jan 31, 1991155-day reviewClass II21 CFR 884.3200

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

Sil-Med Corp. · HFL Drain, Cervical

Cleared on Jan 31, 1991 after a 155-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 31, 1991
Review
155 days
Class
Class II
Product code
HFL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K903989Source: 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 HFL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 HFL devices

HFL Drain, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HFL

FDA has decided no HFL device since 2007.

Median 510(k) review, days · HFL

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

Recalls per year · HFL

No recall names HFL since 2007.

Adverse event reports per year · HFL

No MAUDE report names HFL since 2007.

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—00
20230—00
20240—00
20250—00
20260—0—

More from Sil-Med Corp.

29 FDA decisions under this applicant name. See the company

  • K972521Navigator (Stylet) 2006Sil-Med Corp. · 1997
  • K961392Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IISil-Med Corp. · 1997
  • K961194Antimicrobial Mediastinal Silicone DrainSil-Med Corp. · 1996
  • K961295Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out TrocarSil-Med Corp. · 1996
  • K960099Penrose Drain Models 6001 - 6007Sil-Med Corp. · 1996

https://510kreport.com/device/K903989 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903989: Sil-Med T-Tube Drain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903989

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