510(k) Report

510(k) · Cleared

Cleared

7300 Nasal Cpap System

K943509510(k) TraditionalCleared Aug 5, 199416-day reviewClass II21 CFR 868.5905

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

Healthdyne Technologies, Inc. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Aug 5, 1994 after a 16-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 31 later devices descend from it.

Decided
Aug 5, 1994
Review
16 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1998: 1 descendant cleared1999: 1 descendant cleared2000: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2008: 3 descendants cleared2003: 2 descendants cleared2005: 2 descendants cleared2007: 1 descendant cleared2006: 1 descendant cleared2010: 2 descendants cleared2014: 2 descendants cleared2012: 2 descendants cleared2009: 1 descendant cleared2013: 3 descendants cleared2015: 1 descendant cleared2018: 2 descendants cleared2020: 2 descendants cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK943509 7300 Nasal Cpap SystemHealthdyne Technologies, Inc. · 1994
  2. Descendant · cites it directly · 30 of its ownK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
  3. Descendant · 2 generations on · 29 of its ownK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
  4. Descendant · 3 generations on · 28 of its ownK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
  5. Descendant · 4 generations on · 22 of its ownK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
  6. Descendant · 5 generations on · 20 of its ownK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

1996: 11998: 11999: 12000: 12002: 12003: 22004: 12005: 22006: 12007: 12008: 32009: 12010: 22012: 22013: 32014: 22015: 12018: 22020: 22023: 1
1996high 3 (2008) · low 0 (1997)2026

Most influential descendants

Showing 5 of 31 · See all
  • K960518The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996 · cites it directly30descendants
  • K980365Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998 · 2 generations on29descendants
  • K991150Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999 · 3 generations on28descendants
  • K993584Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000 · 4 generations on22descendants
  • K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003 · 5 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K9435097300 Nasal Cpap SystemHealthdyne Technologies, Inc.1994—
+1K960518The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp.1996—
+2K980365Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc.1998—
+3K991150Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt.1999—
+4K993584Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt.2000—
+5K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
199910
200010
200210
200320
200410
200520
200610
200710
200830
200910
201020
201220
201330
201420
201510
201820
202020
202310
FIG. 1 — Lineage of K943509, 1994–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BZD device

  1. #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K960518The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp.199630

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, K960518 (Puritan Bennett Corp., 1996) has gone furthest, with 30 descendants of its own.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZD

7in 2025

2007: 212008: 172009: 232010: 122011: 232012: 212013: 232014: 142015: 112016: 122017: 52018: 52019: 62020: 62021: 62022: 42023: 52024: 102025: 72026 (partial year): 10
2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007: 83 days median2008: 108 days median2009: 90 days median2010: 122 days median2011: 125 days median2012: 133 days median2013: 127 days median2014: 172 days median2015: 224 days median2016: 217 days median2017: 221 days median2018: 280 days median2019: 231 days median2020: 137 days median2021: 192 days median2022: 253 days median2023: 204 days median2024: 132 days median2025: 189 days median2026 (partial year): 214 days median
2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007: 292008: 22009: 12011: 12019: 4, 4 Class I2023: 8, 7 Class I2026 (partial year): 2, 2 Class I
2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007: 652008: 672009: 1472010: 1432011: 1892012: 1392013: 822014: 862015: 1142016: 1182017: 1482018: 1012019: 1882020: 1262021: 6,0662022: 90,7682023: 27,9872024: 68,2622025: 60,279
2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, 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
200721832965
200817108267
200923901147
2010121220143
2011231251189
2012211330139
201323127082
201414172086
2015112240114
2016122170118
201752210148
201852800101
201962314 (4)188
202061370126
2021619206,066
20224253090,768
202352048 (7)27,987
202410132068,262
20257189060,279
2026102142 (2)—

More from Healthdyne Technologies, Inc.

9 FDA decisions under this applicant name. See the company

  • K983572Simon Multichannel Recording System, Model 5500Healthdyne Technologies, Inc. · 1999
  • K974453Nasal Interface Model 7910Healthdyne Technologies, Inc. · 1998
  • K974879Model 7410 VoyagerHealthdyne Technologies, Inc. · 1998
  • K972614Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605Healthdyne Technologies, Inc. · 1998
  • K971867Alice 4R SystemHealthdyne Technologies, Inc. · 1997

Recent decisions in BZD

The BZD category page

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https://510kreport.com/device/K943509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943509: 7300 Nasal Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943509

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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