Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

BYX — Predicate Candidate Screening

62 FDA 510(k) clearances under this product code; the 50 most recent screened below.

27 daysmedian FDA review time
92 days90th percentile
62clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K011134OXYGEN SUPPLY TUBING, MODEL 1115Hudson Respiratory Care, Inc.2001-06-13610
K955656NORTH STATE PLASTICS AEROSOL TEENorth State Plastics, Inc.1996-03-06850
K943110GAS SAMPLING INTERFACESCoast Medical, Inc.1994-08-19510
K935835BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIESBusse Hospital Disposables, Inc.1994-01-12360
K931033MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETSMedical Fittings, Inc.1993-06-01920
K931043MF OHMEDA STYLE MEDICAL GAS WALL OUTLETSMedical Fittings, Inc.1993-06-01920
K913422OXYGEN TUBING, 81503Specialty Packaging Producs, Inc.1992-01-301830
K914980HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIESMedical Fittings, Inc.1992-01-21760
K912763OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS)Medical Fittings, Inc.1991-10-151130
K905091VARIOUS MALE QUICK CONNECTS.Medical Fittings, Inc.1991-03-041100
K905094SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONNMedical Fittings, Inc.1990-11-2070
K904757OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERSMedical Fittings, Inc.1990-10-31120
K904702MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTSMedical Fittings, Inc.1990-10-31150
K904701MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONNMedical Fittings, Inc.1990-10-31150
K904337OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN.Medical Fittings, Inc.1990-10-04140
K901983OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.Medical Fittings, Inc.1990-08-141040
K901961OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLERMedical Fittings, Inc.1990-08-141050
K863912THE MMG 5 IN 1 CONNECTORMedical Marketing Group1986-10-27190
K860877FLEXTUBE, CONNECTING TUBINGDhd Medical Products Div. Diemolding Corp.1986-03-20230
K854239OXYCOILChad Therapeutics, Inc.1985-11-14240
K853569MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBINGMedipart Jerry Alexander1985-11-07730
K852081PENNINE OXYGEN LINK TUBINGPennine Medical , Ltd.1985-06-14320
K841901OXYMIZER FLOW RESTRICTORChad Therapeutics, Inc.1984-07-23770
K840790UNIVERSAL OXYGEN TUBING CONNECTORCherry Plastics, Inc.1984-03-30560
K832660OXYGEN CONNECTING TUBESET-RESPIRATORYSan Diego Plastics, Inc.1983-09-26490
K831146OXYCOILChanning Corp.1983-05-16380
K831082CONNECTING TUBINGThe Kendall Company Div. of Tyco Healthcare Group1983-05-09350
K830988OXYGEN CONNECTING TUBEMedovations, Inc.1983-05-03350
K823246AUSTIN INHALATOREms Industries, Inc.1982-12-16450
K823142OXYGEN TUBINGSSeven Harvest Intl. Import & Export1982-11-29350
K813074CONNECTORS & ADAPTERSSeven Harvest Intl. Import & Export1981-12-31590
K813197OXYGEN CONNECTING TUBENorthern Medical Industries1981-12-18350
K813234OHIO AIR ADAPTORTimeter Instrument Corp.1981-12-08210
K811550TIMETER PRODUCED CHEMETRON (NCG) AIRTimeter Instrument Corp.1981-06-18160
K811551TIMETER PRODUCED OHIO OXYGEN ADAPTORTimeter Instrument Corp.1981-06-18160
K811549TIMETER PRODUCED SCHRADER OXYGEN ADAPTORTimeter Instrument Corp.1981-06-18160
K810652TUBING CONNECTORSFirst Industries, Inc.1981-03-31210
K810344OXYGEN TUBINGTodd Industries, Inc.1981-03-17350
K810362CORRUGATED FLEX TUBINGTodd Industries, Inc.1981-03-17340
K810374CORRUGATED FLEX TUBING #6000,Todd Industries, Inc.1981-03-13290
K802071OXYGEN SUPPLY TUBINGAuburn Components1980-09-16200
K801514TIMETER PRODUCED PURRITAN BENNETT O2 ADPTimeter Instrument Corp.1980-07-14140
K801261DISPOSABLE COUPLING ADAPTORIntec Medical, Inc.1980-06-09120
K801260DISPOSABLE PRESSURE LINE ADAPTORIntec Medical, Inc.1980-06-0470
K801190OXYGEN TUBING (CRUSH RESISTANT)/VINYL TPAirlife, Inc.1980-05-2340
K800664SURE FLOW TUBINGB & F Medical Products, Inc.1980-04-0270
K800509CONNECTING TUBESMedi-Craft , Ltd.1980-03-25210
K800504OXYGEN CONNECTING TUBESMedi-Craft , Ltd.1980-03-18140
K791851RED CAP, M-502Mem Medical, Inc.1979-10-01120
K791848RESPIROMETER MANIFOLD M-505Mem Medical, Inc.1979-10-01120

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda