Atlas FDA

TRANSPAC(R) II, DISPOSABLE TRANSDUCER

FDA 510(k) clearance K884823 · decided 1990-07-03

Clearance details

K-number
K884823
Device name
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1988-11-18
Decision date
1990-07-03
Days to decision
592 days
Clearance type
Traditional
Product code
GWM
Device class
2
Regulation number
882.1620
Medical specialty
Neurology
Advisory committee
Neurology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Abbott Laboratories

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Pressio 3 Multi-parameter Neuromonitoring System (K252241)Sophysa2026-04-10
NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL (K250285)Raumedic AG2025-08-29
B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (K240821)Braincare Desenvolvimento E Inovação Tecnológica S.A.2024-07-18
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (K232890)Integra Lifesciences Production Corporation2024-02-04
B4C System (K201989)Braincare Desenvolvimento E Inovacao Tecnologica S.A.2021-10-08
CereLink ICP Monitor (K210993)Integra Lifesciences Production Corporation2021-04-30
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level (K201118)Medtronic, Inc.2020-05-26
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags (K200630)Medtronic, Inc.2020-04-09
Becker External Drainage and Monitoring System (K200456)Medtronic, Inc.2020-03-26
BcSs-PICNI-2000 Sensor (K182073)Braincare Desenvolvimento E Inovacao Tecnologica S.A.2019-10-17
CereLink ICP Monitor, CereLink ICP Extension Cable (K183406)Integra Lifesciences Corp.2019-01-11
AURA ICP MONITORING SYSTEM (K172209)Branchpoint Technologies, Inc.2018-05-18

Recalls involving this device

RecordFirmDate
Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir. recall (Z-0617-05)Hospira Inc.2005-03-15
Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir. recall (Z-0618-05)Hospira Inc.2005-03-15
Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir. recall (Z-0619-05)Hospira Inc.2005-03-15
Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir. recall (Z-0620-05)Hospira Inc.2005-03-15

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30