510(k) Report

FDA applicant

Sleepnet Corporation

Hampton, NH23 decisions1996–20267 recalls

FDA records 23 decisions for Sleepnet Corporation (Hampton, NH) from 1996 to 2026: 23 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and CBK (Ventilator, Continuous, Facility Use). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 203 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 15 of them its own earlier devices. 7 recalls are linked to its devices, 7 Class I.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Sleepnet Corporation’s devices, and how often a recall has named them.

FDA decisions per year

5in 2024

2007: 12009: 12011: 12012: 32019: 22021: 12022: 12024: 52026 (partial year): 1
2007high 5 (2024) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

7in 2024

2024: 7, 7 Class I
2007high 7 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sleepnet Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sleepnet Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • BZDVentilator, Non-Continuous (Respirator)18decisions
  • CBKVentilator, Continuous, Facility Use4decisions
  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)1decision

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 129 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 203 days; 9 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 28 predicates; 15 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 15 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837Sleepnet Corporation · 20064cite it
  • K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 20073cite it
  • K021534IQ Nasal Mask, Model 50160 Rev. DSleepnet Corporation · 20022cite it
  • K090935Minime Pediatric MaskSleepnet Corporation · 20092cite it
  • K102317IQ Ventilation Nasal MaskSleepnet Corporation · 20112cite it
  • K993269IQ Nasal Mask, Model P/N 50160Sleepnet Corporation · 19992cite it

What has FDA decided for it lately?

  • K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation · 2026
  • K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face…Sleepnet Corporation · 2024
  • K241943Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented MaskSleepnet Corporation · 2024
  • K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation · 2024
  • K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented…Sleepnet Corporation · 2024
  • K241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskSleepnet Corporation · 2024
  • K211274iQ 2 Nasal Mask, Phantom 2 Nasal MaskSleepnet Corporation · 20222 Class I recalls
  • K203601Innova Nasal Non-Vented MaskSleepnet Corporation · 2021

All 23 as Sleepnet Corporation →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K190533Mojo 2 Full Face AAV Non Vented Mask, All SizesMar 1, 2024Class I
  • K211274Phantom 2 Nasal Vented MaskMar 1, 2024Class I
  • K190254Mojo 2 Full Face Vented Mask, All SizesMar 1, 2024Class I
  • K211274iQ 2 Nasal Vented MaskMar 1, 2024Class I
  • K190533Mojo 2 Full Face Non Vented Mask, All SizesMar 1, 2024Class I
  • K120463Mojo Full Face with Headgear, All SizesMar 1, 2024Class I