Atlas FDA

OKO

17 FDA 510(k) clearances · Product code

101 daysmedian time to decision
250 days90th percentile
17clearances measured

FDA profile

Official device name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4683
Medical specialty
General, Plastic Surgery
FDA definition
A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.
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RecordFirmDate
NPseal (K251156)Guard Medical, Inc.2025-05-15
NPseal (K250708)Guard Medical, Inc.2025-04-08
NPseal (20 and 25) (K241522)Guard Medical, Inc.2024-08-15
NPseal (Small, Medium, Large) (K240244)Guard Medical, Inc.2024-02-29
NPseal (K212971)Guard Medical, Inc.2022-02-10
NPseal (K211130)Guard Medical, Inc.2021-05-14
NPseal (K200305)Guard Medical, Inc.2020-05-26
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System (K193185)Benq Materials Corporation2020-05-04
SNaP Wound Care System (K151710)Spiracur, Inc.2015-11-19
SNaP Wound Care System (K142272)Spiracur, Inc.2014-11-25
SNAP WOUND CARE SYSTEM (K132080)Spiracur, Inc.2014-03-12
CISNAP CLOSED INCISION SYSTEM (K133137)Spiracur, Inc.2014-02-25
SNAP WOUND CARE SYSTEM (K113032)Spiracur, Inc.2011-12-01
SNAP WOUND CARE SYSTEM (K112341)Spiracur, Inc.2011-08-29
SNAP (R) WOUND CARE SYSTEM (K111393)Spiracur, Inc.2011-07-28
CI-SNAP WOUND CARE SYSTEM (K111006)Spiracur, Inc.2011-07-21
SNAP WOUND CARE DEVICE (DEN080011)Spiracur, Inc.2009-08-07

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Every clearance here is in the API, with alerts when new ones post.