Atlas FDA

CAM

8 FDA 510(k) clearances · Product code

84 daysmedian time to decision
134 days90th percentile
8clearances measured

FDA profile

Official device name
Yoke Assembly, Medical Gas
Device class
Class I (low risk)
Regulation
21 CFR 868.6885
Medical specialty
Anesthesiology
Adverse events (MAUDE)
1994: 1 · 1996: 2 · 2000: 1 · 2001: 1 · 2003: 3 · 2009: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
YOKE ASSEMBLY MEDICAL GAS (K935283)American Gage & Medical, Inc.1994-03-11
PENOX DUAL FLOW MINIFOLD (K851217)Penox Technologies, Inc.1985-06-18
FILL HOSE SAFETY ADAPTER (K851219)Penox Technologies, Inc.1985-06-18
PENOX DUAL FEED MANIFOLD (K851216)Penox Technologies, Inc.1985-06-18
T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER (K851215)Penox Technologies, Inc.1985-06-18
GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB (K840326)Siemens Elema AB1984-06-07
OXYGEN/NITROUS OXIDE OUTLET (K780365)Spica, Inc.1978-03-30
OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE (K770426)Bel-Med, Inc.1977-03-15

Track CAM automatically

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