510(k) Report

510(k) · Cleared

Cleared

Skin Saver (TM) Tubing Holder, Model 1921 Modified

K921496510(k) TraditionalCleared Aug 14, 1992158-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

Alpine Specialties, Inc. · CAT Cannula, Nasal, Oxygen

Cleared on Aug 14, 1992 after a 158-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Aug 14, 1992
Review
158 days
Class
Class I
Product code
CAT
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K921496Source: 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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 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 Alpine Specialties, Inc.

2 FDA decisions under this applicant name. See the company

  • K912197Skin Saver (TM) Tubing Holder, Model 467Alpine Specialties, Inc. · 1991

Recent decisions in CAT

The CAT category page

  • K011125Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by HrciHudson Respiratory Care, Inc. · 2001
  • K935533Nasal CannulaPuritas Health Care, Inc. · 1994
  • K9223974 Sure TM Nasal Oxygen CannulaBoston Pacific Medical, Inc. · 1993
  • K920573Cannula Nasal OxygenB & F Medical Products, Inc. · 1992
  • K913421Nasal Oxygen Cannula, 81585, 81587 & 81589Specialty Packaging Producs, Inc. · 1991

https://510kreport.com/device/K921496 · printed Nov 4, 2026

Cite this page

510(k) Report. “K921496: Skin Saver (TM) Tubing Holder, Model 1921 Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K921496

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