Panels › General, Plastic Surgery › Product code BTA · Class 2
Pump, Portable, Aspiration (Manual Or Powered)
Regulation 878.4780
7510(k)s in 12 months (160 all time)
0recalls in 12 months (21 all time)
16recalls that name a 510(k)
Top companies in BTA
| Company | 510(k)s | Recalls |
|---|---|---|
| Medela AG | 10 | 0 |
| Ohio Medical Corporation | 2 | 5 |
| S S C O R Inc | 0 | 6 |
| Aeros Instruments, Inc. | 5 | 0 |
| Egnell, Inc. | 5 | 0 |
| Precision Medical, Inc. | 3 | 2 |
| Thomas Industries | 5 | 0 |
| Sscor | 4 | 0 |
| Advanced Cytometrix, Inc. | 3 | 0 |
| Haemonetics Corp. | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 18, 1995 | K944399 | MEDI-PUMP Thomas Industries | BTA |
| Jan 5, 1995 | K941096 | ELECTRIC VACUM PUMP Impact Instrumentation, Inc. | BTA |
| Dec 22, 1994 | K945929 | S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP Sscor | BTA |
| Nov 8, 1994 | K944818 | COOK ASPIRATION/IRRIGATION UNIT Cook Urological, Inc. | BTA |
| Sep 7, 1994 | K944116 | FREEDOM ASPIRATOR, MODEL 6000 Stackhouse, Inc. | BTA |
| Aug 26, 1994 | K933757 | HAND-HELD IRRIGATION PUMP Ximed Medical Systems | BTA |
| Jun 28, 1994 | K942033 | R&D BATTERIES, PART NOS. 5243, 5104, AND 5481 R & D Batteries, Inc. | BTA |
| May 20, 1994 | K933902 | MOBLVAC III Aeros Instruments, Inc. | BTA |
| May 18, 1994 | K941578 | STATVAC PORTABLE SUCTION UNIT Laerdal California, Inc. | BTA |
| May 3, 1994 | K940934 | LIFE VAC Life Support Products, Inc. | BTA |
| May 2, 1994 | K934976 | INSTAVAC II Aeros Instruments, Inc. | BTA |
| Feb 17, 1994 | K931348 | BATTERY PACK #1005NC Portable Power Systems, Inc. | BTA |
| Nov 12, 1993 | K932051 | TOTE-L-VAC Aeros Instruments, Inc. | BTA |
| Oct 7, 1993 | K932494 | PM PUMP ASPIRATOR Precision Medical, Inc. | BTA |
| Jul 9, 1993 | K926566 | CARE-E-VAC Aeros Instruments, Inc. | BTA |
| Jun 18, 1993 | K930549 | LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000 Rustronics, Inc. | BTA |
| Mar 23, 1993 | K920628 | QUINEVAC EVACUATOR/ASPIRATOR Recto Molded Products, Inc. | BTA |
| Nov 18, 1992 | K922176 | INTELIJET SUCTION SUPPLY Smith & Nephew Dyonics, Inc. | BTA |
| Sep 17, 1992 | K921107 | AUTOVAC Life Support Products, Inc. | BTA |
| Sep 9, 1992 | K921611 | MADAVAC 190 Mada Medical Products, Inc. | BTA |
| Mar 20, 1991 | K910271 | VACPAC PORTABLE ASPIRATION SYSTEM Jedmed Instrument Co. | BTA |
| Sep 25, 1989 | K891129 | SERIES 3 GENERAL SUCTION SYSTEM Ultravac, Inc. | BTA |
| Oct 3, 1988 | K883582 | VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM Surgidyne, Inc. | BTA |
| Mar 21, 1988 | K874157 | LASE EVACUATOR/ASPIRATOR Lase, Inc. | BTA |
| Nov 25, 1987 | K873940 | CREAT BRAND O-RISE GENERAL ASPIRATOR Aesthetech Corp. | BTA |
| Sep 25, 1987 | K873462 | VAN DELLEN ASPIRATOR Van Dellen, Ltd. | BTA |
| Aug 18, 1987 | K871570 | APEX ALPHA VACUUM PUMP Apex Medical, Inc. | BTA |
| Mar 6, 1987 | K870094 | BUNN MODEL 530 ASPIRATOR The John Bunn Co. | BTA |
| Nov 3, 1986 | K862875 | E-VAC(TM) Laerdal California, Inc. | BTA |
| Aug 14, 1986 | K862569 | HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS) Jedmed Instrument Co. | BTA |
| Aug 4, 1986 | K862751 | USA ASPIRATOR U. S. A. Medical Corp. | BTA |
| Feb 12, 1986 | K860030 | SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID Surgidyne, Inc. | BTA |
| Feb 12, 1986 | K854844 | LS1000 SURGICAL ASPIRATOR II Engineering, Inc. | BTA |
| Dec 13, 1985 | K851560 | PORTASPIR II Roseburg SA | BTA |
| Nov 25, 1985 | K853917 | EGNELL COMPACT SUCTION PUMP Egnell, Inc. | BTA |
| Nov 25, 1985 | K853909 | EGNELL UNIVERSAL SUCTION PUMP Egnell, Inc. | BTA |
| Sep 16, 1985 | K850946 | SURGICAL ASPIRATOR Medicalex, FR | BTA |
| Aug 15, 1985 | K852646 | THERMATIC SUCTION PUMP H.C.H. Products, Inc. | BTA |
| Jan 25, 1985 | K844200 | K.M. PRODUCTS ASPIRATOR Km Products | BTA |
| Nov 16, 1984 | K843644 | STORZ ASPIRATION MACHINE SAM 5000 Storz Instrument Co. | BTA |
| Oct 31, 1984 | K843693 | JACOBS HIGH VACUUM SUCTION UNIT 05-2570 J. Sklar Mfg. Co., Inc. | BTA |
| Oct 11, 1984 | K843750 | APPARATUS, SUCTION, WARD USE, PORTAB- H.C.H. Products, Inc. | BTA |
| Aug 10, 1984 | K842204 | DMI ASPIRATOR 500 Dean Medical Instruments, Inc. | BTA |
| Jul 18, 1984 | K841399 | BRONCHOSCOPE SUCTION UNIT Keymed, Inc. | BTA |
| Jun 14, 1984 | K841903 | FRASER HARLAKE EMERG. CARE SUCTION SYS Fraser Harlake, Inc. | BTA |
| May 21, 1984 | K840803 | GRAMS ASPIRATOR S-300 Grams Medical, Inc. | BTA |
| Mar 12, 1984 | K840110 | LAERDAL SUCTION UNIT Laerdal Medical Corp. | BTA |
| Dec 22, 1983 | K833785 | EMERGENCY ASPIRATOR Vitalograph , Ltd. | BTA |
| Oct 20, 1983 | K832274 | ASPIRATOR Wells Johnson Co. | BTA |
| Oct 4, 1983 | K832100 | PSI SURGICAL ASPIRATOR Advanced Biosearch Assn. | BTA |
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