Ackrad Laboratories
Cranford, NJ, US
Ackrad Laboratories appears in FDA device records in Cranford, NJ. FDA records list 42 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 42
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 42 510(k) clearances for Ackrad Laboratories between 1979 and 2002. The busiest year on record is 1987, with 6. The most recent is 2002, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 4 |
| 1982 | 4 |
| 1983 | 3 |
| 1984 | 5 |
| 1985 | 3 |
| 1986 | 1 |
| 1987 | 6 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 1 |
| 2002 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K021272 | SIB CATHETER, MODEL 61-7005 | LKF | Substantially Equivalent | |
| K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY | LKF | Substantially Equivalent | |
| K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 | LKF | Substantially Equivalent | |
| K970492 | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER | LKF | Substantially Equivalent | |
| K961752 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | LKF | Substantially Equivalent | |
| K952542 | ACKRAD ESOPHAGEAL BALLOON CATHETER SET | BZC | Substantially Equivalent | |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | MFD | Substantially Equivalent | |
| K953034 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | LKF | Substantially Equivalent | |
| K915813 | ACKRAD ERCP CONTRAST DELIVERY SET | FGE | Substantially Equivalent | |
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | KFG | Substantially Equivalent | |
| K911780 | INFANT NASAL CANNULAE ASSEMBLY, MODIFIED | BZD | Substantially Equivalent | |
| K901574 | ACKRAD MPR DRAINAGE CATHETER SET | KNT | Substantially Equivalent | |
| K895031 | MODIFIED INFANT NASAL CANNULAE ASSEMBLY | BZD | Substantially Equivalent | |
| K881680 | ACKRAD H/S PROCEDURE TRAY | HIG | Unknown | |
| K880161 | ACKRAD PEDIATRIC C.P.A.P. SYSTEM | BYE | Substantially Equivalent | |
| K874312 | ACKRAD RETROGRADE URETHROGRAPHY SET | KOD | Substantially Equivalent | |
| K874293 | ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET | KOD | Substantially Equivalent | |
| K872277 | TRAKEFIT TRACHEOSTOMY TUBE HOLDER | CBH | Substantially Equivalent | |
| K864818 | ACKRAD TDI SET | KRB | Substantially Equivalent | |
| K871069 | MODIFIED HYSTEROSALPINGOGRAPY SET | KNA | Substantially Equivalent | |
| K865108 | N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE | BSR | Substantially Equivalent | |
| K854320 | ACKRAD ORAL SUCTION TUBE | BSY | Substantially Equivalent | |
| K852154 | ACKRAD SIALOGRAPHY CATHETER | Substantially Equivalent | ||
| K850784 | BRONCHITRAC L | BSY | Substantially Equivalent | |
| K850309 | COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK | JAY | Substantially Equivalent | |
| K844557 | ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE | BSR | Substantially Equivalent | |
| K842231 | ACKRAD HYSTEROSALPINGOGRAPHY SET | KNA | Substantially Equivalent | |
| K841773 | INFANT NASAL CANNULAE ASSEMBLY | BZD | Substantially Equivalent | |
| K840490 | FLUID REMOVAL ASSEMBLY | FMF | Substantially Equivalent | |
| K840056 | PEDIATRIC INTUBATION CIRCUIT | CAI | Substantially Equivalent | |
| K834089 | COMFIT | JAY | Substantially Equivalent | |
| K833633 | BRONCHITRAC DF DUAL RESP/CATHETER | BSY | Substantially Equivalent | |
| K823936 | CPAP INFANT NASAL CANNULAE SET | BZD | Substantially Equivalent | |
| K822398 | ACKRAD BRONCHITRAC | BSY | Substantially Equivalent | |
| K822228 | GASTRO VAGE SET FOR GASTRIC LAVAGE | KNT | Substantially Equivalent | |
| K820937 | ACKRAD FLUID CONNECTING SET | LHI | Substantially Equivalent | |
| K813607 | ACKRAD N-DO VAGE TUBE | FQH | Substantially Equivalent | |
| K813103 | ACKRAD INCISION & DRAIN SET | KDD | Substantially Equivalent | |
| K811185 | N-D0-SURE | CBH | Substantially Equivalent | |
| K810059 | ENDO-MED TUBE FOR ENDOTRACHEAL MED | CCT | Substantially Equivalent | |
| K810209 | IRRIJET | KYZ | Substantially Equivalent | |
| K790009 | ICE PACK, REUSABLE FLEXIBLE | IME | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KFGAntiserum, Positive Control, Aspergillus Spp.
- CCTApplicator (Laryngo-Tracheal), Topical Anesthesia
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BZCCalculator, Pulmonary Function Data
- MFDCannula, Intrauterine Insemination
- LKFCannula, Manipulator/Injector, Uterine
- KODCatheter, Urological
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- CBHDevice, Fixation, Tracheal Tube
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic
- HIGInsufflator, Hysteroscopic
- KDDKit, Surgical Instrument, Disposable
- FQHLavage, Jet
- IMEPack, Hot Or Cold, Reusable
- KRBProbe, Thermodilution
- LHISet, I.V. Fluid Transfer
- FGEStents, Drains And Dilators For The Biliary Ducts
- BSRStylet, Tracheal Tube
- JAYSupport, Breathing Tube
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- KNTTubes, Gastrointestinal (And Accessories)
- BZDVentilator, Non-Continuous (Respirator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain