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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

The John Bunn Co. — Predicate Candidate Screening

20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

34 daysmedian FDA review time
148 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K900854JOHN BUNN: MEDIX COMPACT TRAVELLERThe John Bunn Co.1990-04-23600
K883216BUNN MODEL 50 OXYGEN FLOW CONTROLLERThe John Bunn Co.1988-08-18200
K873071BUNN CONCENTRATOR MODEL 2100 SERIESThe John Bunn Co.1987-09-15410
K870094BUNN MODEL 530 ASPIRATORThe John Bunn Co.1987-03-06560
K861435BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVEThe John Bunn Co.1986-11-072040
K861199BUNN MODEL 22 OXYGEN FLOW CONTROLLERThe John Bunn Co.1986-08-261480
K862628BUNN MODEL 510 MEDICATION COMPRESSORThe John Bunn Co.1986-08-07280
K855208BUNN LITE OXYGEN CONCENTRATORThe John Bunn Co.1986-02-21530
K860060RX02 PLUS OXYGEN CONCENTRATORThe John Bunn Co.1986-02-05300
K843811BUNN 3001 OXYGEN CONCENTRATORThe John Bunn Co.1984-10-0460
K841102BUNN 1000 OXYGEN CONCENTRATORThe John Bunn Co.1984-04-13310
K840534LIQUID OXYGEN SYSTEMThe John Bunn Co.1984-03-02230
K821823I.V. SENTINELThe John Bunn Co.1982-08-16550
K800546BUNN VOLUMAIRE RESPIRATORY EXERCISERThe John Bunn Co.1980-03-25150
K790370BUNN MODEL #40 LOW PRESSURE ALARMThe John Bunn Co.1979-03-28340
K780863MODEL 65 HIGH & LOW PRESSURE ALARMThe John Bunn Co.1978-08-21830
K780862MODEL 290 OXYGEN RICH AIR SUPPLY UNITThe John Bunn Co.1978-08-14760
K781213COMPRESSOR, AIR, MINI-SILENTThe John Bunn Co.1978-07-27170
K761260ARIZONA OXYGEN TIMER DEVICEThe John Bunn Co.1976-12-1680
K760705OXYGEN-RICHThe John Bunn Co.1976-10-05150

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