510(k) Report

510(k) · Cleared

Cleared

Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by Hrci

K011125510(k) TraditionalCleared Jun 13, 200161-day reviewClass I21 CFR 868.5340

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. · CAT Cannula, Nasal, Oxygen

Cleared on Jun 13, 2001 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 13, 2001
Review
61 days
Class
Class I
Product code
CAT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2014: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK011125 Nasal Cannula, with and Without Supply Tubing, and Other Similar…Hudson Respiratory Care, Inc. · 2001
  2. Descendant · cites it directly · 2 of its ownK080527 Twinguard with Capnograph AccessoryTrawax Pty Limited · 2008
  3. Descendant · 2 generations on · 1 of its ownK140473 DualguardFlexicare Medical, Ltd. · 2014
  4. Descendant · 3 generations on · 0 of its ownK240937 AIM (N/A)Inventeur, LLC · 2024

Most influential descendants

Showing 3 of 3 · See all
  • K080527Twinguard with Capnograph AccessoryTrawax Pty Limited · 2008 · cites it directly2descendants
  • K140473DualguardFlexicare Medical, Ltd. · 2014 · 2 generations on1descendant
  • K240937AIM (N/A)Inventeur, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011125Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula…Hudson Respiratory Care, Inc.2001—
+1K080527Twinguard with Capnograph AccessoryTrawax Pty Limited2008—
+2K140473DualguardFlexicare Medical, Ltd.2014—
+3K240937AIM (N/A)Inventeur, LLC2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201410
202410
FIG. 1 — Lineage of K011125, 2001–2024Source: 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 CAT? 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K080527Twinguard with Capnograph AccessoryTrawax Pty Limited20082

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, K080527 (Trawax Pty Limited, 2008) has gone furthest, with 2 descendants of its own.

How does its category compare?

All CAT devices

CAT Cannula, Nasal, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAT

FDA has decided no CAT device since 2007.

Median 510(k) review, days · CAT

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

Recalls per year · CAT

5in 2018

2018: 5
2007high 5 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CAT

79in 2025

2007: 82008: 122009: 192010: 442011: 332012: 502013: 1182014: 1472015: 1092016: 1742017: 1282018: 912019: 1052020: 1352021: 1282022: 742023: 1162024: 752025: 79
2007high 174 (2016) · low 8 (2007)2025

MAUDE reports naming product code CAT, 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—012
20090—019
20100—044
20110—033
20120—050
20130—0118
20140—0147
20150—0109
20160—0174
20170—0128
20180—591
20190—0105
20200—0135
20210—0128
20220—074
20230—0116
20240—075
20250—079
20260—0—

More from Hudson Respiratory Care, Inc.

15 FDA decisions under this applicant name. See the company

  • K031383MODEL 780Hudson Respiratory Care, Inc. · 20033 recalls
  • 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
  • K993355Hudson Rci Concha Column, Cat. NO. 385-40 and Hudson Rci Circuit, Cat. NO. 780-40, 780-41, 780-42, 780-43Hudson Respiratory Care, Inc. · 20001 recall

Recent decisions in CAT

The CAT category page

  • K935533Nasal CannulaPuritas Health Care, Inc. · 1994
  • K9223974 Sure TM Nasal Oxygen CannulaBoston Pacific Medical, Inc. · 1993
  • K921496Skin Saver (TM) Tubing Holder, Model 1921 ModifiedAlpine Specialties, Inc. · 1992
  • K920573Cannula Nasal OxygenB & F Medical Products, Inc. · 1992
  • K913421Nasal Oxygen Cannula, 81585, 81587 & 81589Specialty Packaging Producs, Inc. · 1991

https://510kreport.com/device/K011125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011125: Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by Hrci.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011125

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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