510(k) Report

510(k) · Cleared

Cleared

Hans Rudolph Nasal Cpap Mask

K962848510(k) TraditionalCleared Oct 16, 199686-day reviewClass I21 CFR 868.5580

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

Hans Rudolph, Inc. · BYG Mask, Oxygen

Cleared on Oct 16, 1996 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Oct 16, 1996
Review
86 days
Class
Class I
Product code
BYG
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2001: 1 descendant cleared2003: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962848 Hans Rudolph Nasal Cpap MaskHans Rudolph, Inc. · 1996
  2. Descendant · cites it directly · 2 of its ownK984254 Infant Flow Ncpap MasksSensor Medics Corp. · 1999
  3. Descendant · 2 generations on · 0 of its ownK030563 Arabella Ncpap MasksHamilton Medical AG · 2003
  4. Descendant · 2 generations on · 0 of its ownK012034 Modification to: Sipap Infant Nasal Cpap CircuitSensor Medics Corp. · 2001

Most influential descendants

Showing 3 of 3 · See all
  • K984254Infant Flow Ncpap MasksSensor Medics Corp. · 1999 · cites it directly2descendants
  • K030563Arabella Ncpap MasksHamilton Medical AG · 2003 · 2 generations on0descendants
  • K012034Modification to: Sipap Infant Nasal Cpap CircuitSensor Medics Corp. · 2001 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962848Hans Rudolph Nasal Cpap MaskHans Rudolph, Inc.1996—
+1K984254Infant Flow Ncpap MasksSensor Medics Corp.1999—
+2K030563Arabella Ncpap MasksHamilton Medical AG2003—
+2K012034Modification to: Sipap Infant Nasal Cpap CircuitSensor Medics Corp.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200310
FIG. 1 — Lineage of K962848, 1996–2003Source: 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 BYG? 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 lists a 510(k) statement for it but has not posted the file, 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
K984254Infant Flow Ncpap MasksSensor Medics Corp.19992

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, K984254 (Sensor Medics Corp., 1999) has gone furthest, with 2 descendants of its own.

How does its category compare?

All BYG devices

BYG Mask, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYG

FDA has decided no BYG device since 2007.

Median 510(k) review, days · BYG

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

Recalls per year · BYG

1in 2025

2011: 192017: 12018: 12025: 1
2007high 19 (2011) · low 0 (2007)2026

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

Adverse event reports per year · BYG

23in 2025

2007: 172008: 162009: 142010: 132011: 162012: 192013: 202014: 512015: 632016: 222017: 82018: 392019: 292020: 62021: 122022: 182023: 42024: 92025: 23
2007high 63 (2015) · low 4 (2023)2025

MAUDE reports naming product code BYG, 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—017
20080—016
20090—014
20100—013
20110—1916
20120—019
20130—020
20140—051
20150—063
20160—022
20170—18
20180—139
20190—029
20200—06
20210—012
20220—018
20230—04
20240—09
20250—123
20260—0—

More from Hans Rudolph, Inc.

11 FDA decisions under this applicant name. See the company

  • K071149Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc. · 2008
  • K0308227600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV MasksHans Rudolph, Inc. · 2003
  • K030515Hans Rudolph 7500 Series Reusable Oro-Nasal Niv MasksHans Rudolph, Inc. · 2003
  • K0207597600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra…Hans Rudolph, Inc. · 2002
  • K960401Ultimate SealHans Rudolph, Inc. · 1996

Recent decisions in BYG

The BYG category page

  • K963298First Aid Kit (S)Vector, Inc. · 1996
  • K945482Disposable, Cpap Oxygen MaskFvtnks · 1995
  • K953464Westmed Pediatric & Adult Medium Concentration Oxygen MaskWestmed, Inc. · 1995
  • K953039Various Adult & Child High Con/Nonrebreath Oxy MasksDadsun Corp., Ltd. · 1995
  • K945472Westmed Pediatric and Adult Aerosol MaskWestmed Intl. · 1995

https://510kreport.com/device/K962848 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962848: Hans Rudolph Nasal Cpap Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962848

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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