Atlas FDA

GCX

87 FDA 510(k) clearances · Product code

74 daysmedian time to decision
200 days90th percentile
87clearances measured

FDA profile

Official device name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 65 · 2022: 72 · 2023: 59 · 2024: 65 · 2025: 280 · 2026: 81
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
STRYKER CASSETTE PUMP (K042454)Stryker Endoscopy2004-12-09
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (K992126)Circon Corp.1999-08-03
SUCTION INSTRUMENTATION (K972074)Walter Lorenz Surgical, Inc.1997-07-25
CHASE SUCKER (K971022)Chase Medical, Inc.1997-04-17
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (K964127)Allegiance Healthcare Corp.1996-12-31
CURITY THORACENTESIS TRAY (K964519)Kendall Healthcare Products Co. Div.Of Tyco Health1996-12-20
STRYKER SUCTION REGULATOR (K963648)Stryker Endoscopy1996-11-26
RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (K962920)R&S Surgical, LLC1996-10-21
MEDCARE SUCTION CONNECTING TUBING (K961880)Medcare Medical Group, Inc.1996-07-19
CPR YANKAUER (K960223)Custom Pack Reliability1996-03-28
MEDCARE YANKAUER SUCTION DEVICE (K954869)Medcare Custom Packaging, Inc.1996-01-19
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) (K954726)Stryker Endoscopy1995-11-29
SUCTION TIP CLEANER CUP (K952219)Moore/Gobel1995-11-15
NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM (K951119)American Hydro-Surgical Instruments, Inc.1995-06-13
SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES (K950464)Sscor1995-04-25
INAMED DEVELOPMENT ASPIRATION TIP (K931548)Inamed Development Co.1994-01-10
OEM MULTI-VAC POWERED SUCTION PUMP (K924570)Oem Medical Div.1993-08-05
THE MEDIC TM (K920912)Medical and Environment Designs, Inc.1993-07-30
PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS (K924337)Deknatel, Inc.1993-07-28
MEDIVAC (K924577)Medisonic U.S.A., Inc.1993-03-23
TAHOE SUCTION IRRIGATOR (K911238)Tahoe Pro Instruments1992-11-27
MODEL SLASE 210 HOLMIUM LASER SYSTEM (K920248)Sunrise Technologies, Inc.1992-07-21
SUCTION CONNECTING TUBING (K914601)Bemis Mfg. Co.1992-02-07
XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL (K912753)Xomed-Treace, Inc.1991-09-23
COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM (K910377)CooperSurgical, Inc.1991-04-19
LAPAROMED CHOLANGIOGRAM VACUUM DEVICE (K910218)Laparomed Corp.1991-04-08
THORA-KLEX CHEST DRAINAGE UNIT (K905448)Davol, Inc.1991-03-27
CONTAIN(TM) (K895859)Arbor Technologies, Inc.1991-02-07
ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. (K896134)Goosen Enterprises, Inc.1990-08-30
CODMAN SUCTION PATTIE (K901937)Codman & Shurtleff, Inc.1990-07-16
EQUI-GUARD (ASPIRATOR FILTER) (K902089)Equi-Tron Mfg., Inc.1990-07-06
MANIFOLD (K896804)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-08
YANKAUER SUCTION TUBE-RIGID TYPE (K896558)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-06
UNIVERSAL POOLE SUCTION TUBE (K896556)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-06
TUBING CONNECTORS (K896563)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-06
YANKAUER SUCTION TUBE-FLEXIBLE TYPE (K896557)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-06
STOPCOCK (K896562)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-06
VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM (K894695)Medistad Corp.1990-01-22
STERILE SALINE - FOR SUCTION CATHETER LUBRICATION (K895039)Aplicare, Inc.1989-10-03
MECONIUM ASPIRATOR (K893649)Gish Biomedical, Inc.1989-08-21
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER (K893741)Abbott Laboratories1989-08-17
SUCTION TUBES: HOUSE, BARON (K892549)Zinnanti Surgical Instruments, Inc.1989-05-18
PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM (K890129)Deknatel, Inc.1989-04-10
PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN (K890431)Deknatel, Inc.1989-04-04
RECEPTAL SAF-GARD(TM) SYSTEM (K885208)Abbott Laboratories1989-03-17
VAC-RITE (K885334)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-03-08
REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES (K884103)Boehringer Laboratories1989-03-03
PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE (K881252)Deknatel, Inc.1988-06-17
CONTAIN(TM) (K874505)Arbor Technologies, Inc.1988-05-20
CSPI SPECIMEN TRAP (NON-STERILE) (K870874)Custom Surgical Products, Inc.1988-04-19
CERULLO SUCTION REGULATOR (K880704)Aesculap Instruments Corp.1988-03-29
EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000 (K873489)J. H. Emerson Co.1987-12-29
OHMEDA POSI-PULSE SUCTION UNIT (K861261)Ohmeda Medical1986-05-30
BOEHRINGER LABORATORIES SUCTION INTERMITTOR (K853095)Boehringer Laboratories1985-08-23
MEDICAL/SURGICAL SUCTION SYSTEM (K851384)Puritan Bennett Corp.1985-05-08
RICO RS-6X EMERGENCY MEDICAL ASPIRATOR (K844882)Rico Suction Laboratories, Inc.1985-03-01
RICO RS4-XP EMERGENCY MEDICAL ASPIRATOR (K844881)Rico Suction Laboratories, Inc.1985-03-01
ACCURATE MEASUREMENT DEVICE KG-AMD (K833674)Sorensen Research1984-01-25
ACCURATE MEASUREMENT DEVICE EZ-AMD (K833673)Sorensen Research1983-12-29
INVAC W/VARIOUS MODELS (K831116)Pmt1983-08-12
TALL FLOOR STAND TFS-01 (K831939)Sorensen Research1983-07-19
PLEUR-EVAC A-4005 SYSTEM (K823037)Howmedica Corp.1982-10-28
DISPOSABLE COLLECTION BOTTLE W/TUBING (K822311)Ohio Medical Products1982-08-20
SPECIMEN COLLECTORS (K822005)Kelleher Corp.1982-07-28
MEDIGAS SUCTION/DRAINAGE EQUIPMENT (K821841)Linde Div. Union Carbide Corp.1982-07-02
PNEUMO DRAIN T.M. RECORDER #PD-800 (K821160)Sugen Industries, Inc.1982-05-27
THORACIC DRAINAGE SYSTEM (K821023)Howmedica Corp.1982-05-21
PLEURAL DRAINAGE RESERVOIR (K820765)Innovative Surgical Products, Inc.1982-04-15
IMPACT, MODEL 310 (K820424)Impact Instrumentation, Inc.1982-03-12
IMPACT, MODEL 303 (K820337)Impact Instrumentation, Inc.1982-03-02
DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM (K813394)Cox-Uphuff Intl.1982-01-22
ASPIRATOR VENTURI SYSTEM MODEL 55-JV (K813319)J. H. Emerson Co.1981-12-14
VALVED SURGICAL ASPIRATORS (K813029)Imedix1981-12-14
SURGICAL SUCTION INSTRUMENTS-DISPOS. (K812845)Abco Dealers, Inc.1981-11-16
ARGYLE YANKAUER SUCTION TUBE (K813066)Sherwood Medical Co.1981-11-16
ARGYLE COMPACT CHEST DRAINAGE SYS. (K802440)Sherwood Medical Co.1980-10-23
ARGYLE COMPACT CHEST DRAINAGE SYSTEM (K801979)Sherwood Medical Co.1980-09-16
OHIO THORACIC COLLECTION UNIT (K801942)Ohio Medical Products1980-09-16
TUBING, DYNACOR UNIVERSAL (K790055)Medline Industries, Inc.1979-02-22
SUCTION APPARATUS, POWERED BY COMP. AIR (K781988)Farley, W.T.1978-12-12
SUCTION CANISTER (K771737)Bemis Health Care1977-12-20
HEPARINIZED WOUND SUCTION TUBING (K760812)Sherwood Medical Industries1976-11-03
HEPARINIZED SARATOGA SUMP DRAIN (K760813)Sherwood Medical Industries1976-11-03
HEPARINIZED PENROSE TUBING (K760814)Sherwood Medical Industries1976-11-03
JAR, COLLECTOR FOR SUCTION SYSTEMS (K760333)Harris-Lake, Inc.1976-10-27
SUCTION INSTRUMENT, MACBICK POOLE TIP (K760216)C.R. Bard, Inc.1976-08-23
SUCTION INSTRUMENT, MACBICK DIS. FRAZ. (K760217)C.R. Bard, Inc.1976-08-23

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