510(k) Report

510(k) · Cleared

Cleared

Codman Bactiseal Catheters

K003322510(k) TraditionalCleared Oct 1, 2001342-day reviewClass II21 CFR 882.4100

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

Codman & Shurtleff, Inc. · HCA Catheter, Ventricular

Cleared on Oct 1, 2001 after a 342-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided
Oct 1, 2001
Review
342 days
Class
Class II
Product code
HCA
Recalls
None
Predicates
0

13 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 3 descendants cleared2002: 1 descendant cleared2017: 1 descendant cleared2012: 1 descendant cleared2006: 2 descendants cleared2009: 1 descendant cleared2024: 2 descendants cleared2022: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK003322 Codman Bactiseal CathetersCodman & Shurtleff, Inc. · 2001
  2. Descendant · cites it directly · 8 of its ownK020667 Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002
  3. Descendant · 2 generations on · 5 of its ownK053350 Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2006
  4. Descendant · 2 generations on · 4 of its ownK122118 Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc. · 2012
  5. Descendant · cites it directly · 4 of its ownK102589 Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc. · 2011
  6. Descendant · 2 generations on · 3 of its ownK172022 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2002: 12006: 22009: 12011: 32012: 12017: 12022: 12024: 22025: 1
2002high 3 (2011) · low 0 (2003)2026

Most influential descendants

Showing 5 of 13 · See all
  • K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002 · cites it directly8descendants
  • K053350Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2006 · 2 generations on5descendants
  • K122118Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc. · 2012 · 2 generations on4descendants
  • K102589Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc. · 2011 · cites it directly4descendants
  • K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003322Codman Bactiseal CathetersCodman & Shurtleff, Inc.2001—
+1K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.2002—
+2K053350Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.2006—
+2K122118Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc.2012—
+1K102589Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc.2011—
+2K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc.20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200620
200910
201130
201210
201710
202210
202420
202510
FIG. 1 — Lineage of K003322, 2001–2025Source: 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 HCA? 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? (13)

See all 13

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.20028
K102589Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc.20114
K110751Codman Bactiseal Endoscopic Venticular CatheterCodman & Shurtleff, Inc.20112
K110560Medtronic Ares Antibiotic-Impregnated CatheterMedtronic Neurosurgery20111

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, K020667 (Codman & Shurtleff, Inc., 2002) has gone furthest, with 8 descendants of its own.

How does its category compare?

All HCA devices

HCA Catheter, Ventricular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCA

1in 2017

2013: 12017: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCA

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

Recalls per year · HCA

No recall names HCA since 2007.

Adverse event reports per year · HCA

1in 2021

2007: 82008: 32009: 12010: 42011: 192012: 12015: 22016: 12017: 32019: 22020: 12021: 1
2007high 19 (2011) · low 0 (2013)2025

MAUDE reports naming product code HCA, 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—08
20080—03
20090—01
20100—04
20110—019
20120—01
20131—00
20140—00
20150—02
20160—01
20171—03
20180—00
20190—02
20200—01
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Codman & Shurtleff, Inc.

152 FDA decisions under this applicant name. See the company

  • K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
  • K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc. · 2019
  • K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull…Codman & Shurtleff, Inc. · 20171 recall
  • K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagCodman & Shurtleff, Inc. · 2017
  • K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 20171 recall

Recent decisions in HCA

The HCA category page

  • K161731Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp. · 2017
  • K123605Smartflow CatheterMri Interventions, Inc. · 2013
  • K031123Codman Bactiseal Barium Striped CathetersCodman & Shurtleff, Inc. · 20031 recall
  • K021481Bresagen Catheter, Model CS-3000Bresagen, Inc. · 2002
  • K020728Miethke Shunt SystemAesculap, Inc. · 20021 recall

https://510kreport.com/device/K003322 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003322: Codman Bactiseal Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003322

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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