510(k) Report

510(k) · Cleared

Cleared

The Puritan-Bennett 318 Plus Nasal Cpap System

K960518510(k) TraditionalCleared May 9, 199694-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

Puritan Bennett Corp. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on May 9, 1996 as substantially equivalent to K952292 (Puritan Bennett Corp., 1995) and 3 other predicates after a 94-day review. Its family tree reaches back 1 generation to 1990. 30 later devices descend from it.

Decided
May 9, 1996
Review
94 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K903764 (1990). 4 ancestors in all. 30 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1998: 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 clearedK903764 · Companion 318 Nasal Cpap System · Puritan Bennett Corp. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 5 descendants6 generations forward: 3 descendants7 generations forward: 6 descendants8 generations forward: 6 descendants9 generations forward: 1 descendant10 generations forward: 1 descendant K903764 · Companion 318 Nasal Cpap System · Puritan Bennett Corp. · 19900+5+10
  1. Root · 1 generation backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
  2. This deviceK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
  3. Descendant · cites it directly · 29 of its ownK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
  4. Descendant · 2 generations on · 28 of its ownK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
  5. Descendant · 3 generations on · 22 of its ownK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
  6. Descendant · 4 generations on · 20 of its ownK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
  7. Descendant · 5 generations on · 12 of its ownK063476 Breas Isleep 20IBreas Medical AB · 2007

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12000: 12002: 12003: 22004: 12005: 22006: 12007: 12008: 32009: 12010: 22012: 22013: 32014: 22015: 12018: 22020: 22023: 1
1998high 3 (2008) · low 0 (2001)2026

Most influential descendants

Showing 5 of 30 · See all
  • K980365Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998 · cites it directly29descendants
  • K991150Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999 · 2 generations on28descendants
  • K993584Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000 · 3 generations on22descendants
  • K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003 · 4 generations on20descendants
  • K063476Breas Isleep 20IBreas Medical AB · 2007 · 5 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K903764Companion 318 Nasal Cpap SystemPuritan Bennett Corp.1990—
0 (this device)K960518The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp.1996—
+1K980365Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc.1998—
+2K991150Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt.1999—
+3K993584Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt.2000—
+4K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc.2003—
+5K063476Breas Isleep 20IBreas Medical AB2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200010
200210
200320
200410
200520
200610
200710
200830
200910
201020
201220
201330
201420
201510
201820
202020
202310
FIG. 1 — Lineage of K960518, 1990–2023Source: 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 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? (4)

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
*K952292Puritan-Bennett Companion Nasal Cpap System
Summary page 1
…bruar: 1996 Puritan-Bennett 318 Plus Nasal CPAP System CPAP Machine Noncontinuous Ventilator, per 21 CFR 868.5305 and 73 B.ZD Puritan-Bennett C314 Nasal CPAP System, K952292 Puritan-Bennett C318 Nasal CPAP System, K903764 Puritan-Bennett 335 Respiratory Support System, K942210 (pending) Healthdyne T…
Puritan Bennett Corp.1995—
*K903764Companion 318 Nasal Cpap System
Summary page 1
…System CPAP Machine Noncontinuous Ventilator, per 21 CFR 868.5305 and 73 B.ZD Puritan-Bennett C314 Nasal CPAP System, K952292 Puritan-Bennett C318 Nasal CPAP System, K903764 Puritan-Bennett 335 Respiratory Support System, K942210 (pending) Healthdyne Tranquility Quest Compact Nasal CPAP System Model…
Puritan Bennett Corp.1990—
*K942210Puritan-Bennett 335 Respiratory Support System
Cleared while this submission was under review
Summary page 1
…R 868.5305 and 73 B.ZD Puritan-Bennett C314 Nasal CPAP System, K952292 Puritan-Bennett C318 Nasal CPAP System, K903764 Puritan-Bennett 335 Respiratory Support System, K942210 (pending) Healthdyne Tranquility Quest Compact Nasal CPAP System Model 7300, K943509 [99) ] (4) Device Descript…
Puritan Bennett Corp.1996—
*K9435097300 Nasal Cpap System
Summary page 1
…tt C318 Nasal CPAP System, K903764 Puritan-Bennett 335 Respiratory Support System, K942210 (pending) Healthdyne Tranquility Quest Compact Nasal CPAP System Model 7300, K943509 [99) ] (4) Device Description: The 318 Plus Nasal CPAP System is a device used to provide Continuous Positive A…
Healthdyne Technologies, Inc.1994—

Also cleared against K952292: 1 other device →

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K980365Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc.199829

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K980365 (Nellcor Puritan Bennett, Inc., 1998) has gone furthest, with 29 descendants of its own.
  • 1 other device also cites its predicate K952292.

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)—

What is it indicated for?

The intended use of the 318 Plus Nasal CPAP System is to provide Continuous Positive Airway Pressure (CPAP) between 3 and 18 cm H20 to spontaneously breathing adult patients for the treatment of Obstructive Sleep Apnea in a homecare environment. This is the same intended use as for the C314 Nasal CPAP System.

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

Also cleared against K952292

1 other device cites the same predicate.

  • K961626Solo Cpap SystemRespironics, Inc. · 1996

More from Puritan Bennett Corp.

110 FDA decisions under this applicant name. See the company

  • K063650Ventilator with Respiratory Mechanics, Model 840Puritan Bennett Corp. · 2007
  • K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 20061 Class I recall
  • K023225Puritan Bennett Dataflow Data Management SoftwarePuritan Bennett Corp. · 2002
  • K022103Puritan-Bennett 700 Renaissance II Spirometry SystemPuritan Bennett Corp. · 2002
  • K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 20001 Class I recall

Recent decisions in BZD

The BZD category page

  • K260251BreathCare PAP III (YH-390N)Suzhou Yuyue Medical Technology Co., Ltd. · 2026
  • K261262Altis Full Face MaskRespironics, Inc. · 2026
  • K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd. · 2026
  • K253553OrionResmed Corp · 2026
  • K254104ResScan EssentialsResmed Corp · 2026

https://510kreport.com/device/K960518 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960518: The Puritan-Bennett 318 Plus 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/K960518

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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