510(k) Report

510(k) · Cleared

Cleared

Cath-Guide

K955645510(k) TraditionalCleared Mar 12, 199691-day reviewClass I21 CFR 868.6810

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

Hudson Respiratory Care, Inc. · BSY Catheters, Suction, Tracheobronchial

Cleared on Mar 12, 1996 as substantially equivalent to K872621 (Ballard Medical Products, 1987) and 3 other predicates after a 91-day review. Its family tree reaches back 1 generation to 1976.

Decided
Mar 12, 1996
Review
91 days
Class
Class I
Product code
BSY
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K760371 (1976). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1990: 2 other ancestors1987: 1 other ancestorK760371 · Vent-O2-Cath · Dryden Corp. · 197619751980198519901995
Other ancestors, by generation 1 generation back: 3 other ancestors K760371 · Vent-O2-Cath · Dryden Corp. · 19760
  1. Root · 1 generation backK760371 Vent-O2-CathDryden Corp. · 1976
  2. This deviceK955645 Cath-GuideHudson Respiratory Care, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K760371Vent-O2-CathDryden Corp.1976—
0 (this device)K955645Cath-GuideHudson Respiratory Care, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199020
FIG. 1 — Lineage of K955645, 1976–1996Source: 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 BSY? 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
Get a 510(k) Report

What was it cleared against? (6)

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
*K872621Trach Care Catheter
Summary page 1
…Name: CATH-GUIDE Common/Usual Name: Suction catheter, tracheobronchial intended Device: CATH-GUIDE Predicate Devices: Ballard Medical Products, Inc. Trach Care Catheter k872621 Concord/Portex Steri-cath k902383 : Steri-cath double lumen k902687 Maxi-Flo Suction Catheter preamendment Davol Sleeved suction…
Ballard Medical Products19875
*K902383Steri-Cath (TM)
Summary page 1
…e: Suction catheter, tracheobronchial intended Device: CATH-GUIDE Predicate Devices: Ballard Medical Products, Inc. Trach Care Catheter k872621 Concord/Portex Steri-cath k902383 : Steri-cath double lumen k902687 Maxi-Flo Suction Catheter preamendment Davol Sleeved suction catheter only preamendment Dryden…
Concord/Portex1990—
*K902687Steri-Cath-DL
Summary page 1
…ial intended Device: CATH-GUIDE Predicate Devices: Ballard Medical Products, Inc. Trach Care Catheter k872621 Concord/Portex Steri-cath k902383 : Steri-cath double lumen k902687 Maxi-Flo Suction Catheter preamendment Davol Sleeved suction catheter only preamendment Dryden Corporation Vent-02-Cath k760371…
Concord/Portex1990—
*K760371Vent-O2-Cath
Summary page 1
…ri-cath k902383 : Steri-cath double lumen k902687 Maxi-Flo Suction Catheter preamendment Davol Sleeved suction catheter only preamendment Dryden Corporation Vent-02-Cath k760371 Device Description: Hudson RCI intends to introduce a full range of suction catheters and configurations. In summary these are:…
Dryden Corp.1976—
*—Maxi-Flo Suction Catheter
Named without a submission number
—
*—Davol Sleeved suction catheter
Named without a submission number
—

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?

  • 1 of the 4 ancestors has a recall of any class.

How does its category compare?

All BSY devices

BSY Catheters, Suction, Tracheobronchial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSY

FDA has decided no BSY device since 2007.

Median 510(k) review, days · BSY

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

Recalls per year · BSY

1in 2023

2014: 1, 1 Class I2017: 112019: 12020: 12021: 32023: 1
2007high 11 (2017) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BSY

163in 2025

2007: 312008: 172009: 372010: 202011: 422012: 542013: 482014: 652015: 2952016: 3152017: 1132018: 7212019: 1212020: 1492021: 632022: 3092023: 1982024: 2102025: 163
2007high 721 (2018) · low 17 (2008)2025

MAUDE reports naming product code BSY, 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—031
20080—017
20090—037
20100—020
20110—042
20120—054
20130—048
20140—1 (1)65
20150—0295
20160—0315
20170—11113
20180—0721
20190—1121
20200—1149
20210—363
20220—0309
20230—1198
20240—0210
20250—0163
20260—0—

What is it indicated for?

Patients requiring suctioning of airway secretions

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Hudson Respiratory Care, Inc.

15 FDA decisions under this applicant name. See the company

  • K031383MODEL 780Hudson Respiratory Care, Inc. · 20033 recalls
  • K011125Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by HrciHudson Respiratory Care, Inc. · 2001
  • K011134Oxygen Supply Tubing, Model 1115Hudson Respiratory Care, Inc. · 2001
  • K010402Smooth-Flo CircuitHudson Respiratory Care, Inc. · 2001
  • K001213Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60Hudson Respiratory Care, Inc. · 2000

Recent decisions in BSY

The BSY category page

  • K031997Mallinckrodt Dar TY-Care / TY-Care Exel Closed Suction SystemMallinckrodt Dar S.R.L. · 2003
  • K992902Ambu Hand Power Suction PumpAmbu, Inc. · 1999
  • K982945Dual Purpose Closed CatheterSpirit Medical Systems, Inc. · 1998
  • K981910Suction CatheterNi-Med, Inc. · 1998
  • K972258HI-Care Closed Suction SystemMallinckrodt Medical · 1997

https://510kreport.com/device/K955645 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955645: Cath-Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955645

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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