510(k) Report

510(k) · Cleared

Cleared

Automobile Lighter Power Cord

K060549510(k) TraditionalCleared May 4, 200663-day reviewClass II21 CFR 868.5895

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

Pulmonetic Systems, Inc. · CBK Ventilator, Continuous, Facility Use

Cleared on May 4, 2006 as substantially equivalent to K905244 (Aequitron Medical, Inc., 1990) after a 63-day review. Its family tree reaches back 1 generation to 1990.

Decided
May 4, 2006
Review
63 days
Class
Class II
Product code
CBK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K905244 (1990). No later device cites it as a predicate yet.

K905244 · Model LP6 Ventilator, Modification · Aequitron Medical, Inc. · 19901990199520002005
K905244 · Model LP6 Ventilator, Modification · Aequitron Medical, Inc. · 19900
  1. Root · 1 generation backK905244 Model LP6 Ventilator, ModificationAequitron Medical, Inc. · 1990
  2. This deviceK060549 Automobile Lighter Power CordPulmonetic Systems, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K905244Model LP6 Ventilator, ModificationAequitron Medical, Inc.1990—
0 (this device)K060549Automobile Lighter Power CordPulmonetic Systems, Inc.2006—
FIG. 1 — Lineage of K060549, 1990–2006Source: 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), 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 CBK? 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 CBK device

  1. #1 K252663 Inbentus Versatilescore 16.0 · 17 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? (1)

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
*K905244Model LP6 Ventilator, Modification
Summary page 2
…510(k) Clearance Manufacturer LP-6 Ventilator with Puritan Bennett Cigarette Lighter K905244 Pleasanton, CA 94588 Cable Y-CG1 230 "8SN papus)u| swes ¥PSLL N/d pJ0Q Jamod…
Aequitron Medical, Inc.1990—

Also cleared against K905244: 1 other device →

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.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K905244.

How does its category compare?

All CBK devices

CBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBK

4in 2025

2007: 112008: 182009: 122010: 142011: 132012: 172013: 52014: 52015: 72016: 42017: 62018: 42019: 82020: 52021: 62023: 52024: 92025: 42026 (partial year): 3
2007high 18 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBK

163in 2025

2007: 142 days median2008: 115 days median2009: 122 days median2010: 150 days median2011: 192 days median2012: 207 days median2013: 277 days median2014: 439 days median2015: 266 days median2016: 323 days median2017: 280 days median2018: 183 days median2019: 435 days median2020: 176 days median2021: 267 days median2023: 309 days median2024: 203 days median2025: 163 days median2026 (partial year): 235 days median
2007high 439 (2014) · low 115 (2008)2026

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

Recalls per year · CBK

14in 2024

2007: 172008: 232009: 82010: 92011: 122012: 2, 1 Class I2013: 5, 2 Class I2014: 5, 4 Class I2015: 6, 4 Class I2016: 4, 1 Class I2017: 12018: 3, 3 Class I2019: 14, 13 Class I2020: 42021: 21, 19 Class I2022: 8, 4 Class I2023: 4, 3 Class I2024: 14, 14 Class I2026 (partial year): 15, 13 Class I
2007high 23 (2008) · low 0 (2025)2026

Class I (81 since 2007) Class II/III not classified

Adverse event reports per year · CBK

13,991in 2025

2007: 1,5312008: 1,9332009: 1,7662010: 1,7992011: 1,8772012: 5,5092013: 7,9212014: 7,6002015: 11,8762016: 16,0562017: 14,4512018: 9,8492019: 9,1002020: 11,0962021: 13,3222022: 15,9742023: 24,9282024: 20,3362025: 13,991
2007high 24,928 (2023) · low 1,531 (2007)2025

MAUDE reports naming product code CBK, 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
200711142171,531
200818115231,933
20091212281,766
20101415091,799
201113192121,877
2012172072 (1)5,509
201352775 (2)7,921
201454395 (4)7,600
201572666 (4)11,876
201643234 (1)16,056
20176280114,451
201841833 (3)9,849
2019843514 (13)9,100
20205176411,096
2021626721 (19)13,322
20220—8 (4)15,974
202353094 (3)24,928
2024920314 (14)20,336
20254163013,991
2026323515 (13)—

What is it indicated for?

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 Ilbs), who require the following types of ventilatory support:

- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).

- Assist/Control, SIMV or CPAP modes of ventilation.

The ventilator is suitable for use in institutional, home, or transport settings.

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 K905244

1 other device cites the same predicate.

  • K981971Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator with Pressure Limit Model…Bird Products Corp. · 1998

More from Pulmonetic Systems, Inc.

12 FDA decisions under this applicant name. See the company

  • K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc. · 20091 recall
  • K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 20072 Class I recalls
  • K060647LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
  • K051767LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
  • K040790Modification to LTV 1000 Ventilator/Breathing CircuitsPulmonetic Systems, Inc. · 2004

Recent decisions in CBK

The CBK category page

  • K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa · 2026
  • K252663Inbentus VersatileIconic Solutions by Murcia, SL · 2026
  • K251888VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026
  • K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
  • K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P…Fisher & Paykel Healthcare, Ltd. · 2025

https://510kreport.com/device/K060549 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060549: Automobile Lighter Power Cord.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060549

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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