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

Cutter Laboratories, Inc. — Predicate Candidate Screening

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

25 daysmedian FDA review time
98 days90th percentile
39clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K861315HYPERBARIC PENETRATION EXTENSION SETCutter Laboratories, Inc.1986-05-21430
K854106BAYSILEXCutter Laboratories, Inc.1986-03-171600
K842324PERFOURMCutter Laboratories, Inc.1984-11-091490
K834106INTRAVENOUS INFUSION CONTROLLERCutter Laboratories, Inc.1984-05-301830
K832237ORTHOPEDIC CASTING TAPE MAXCASTCutter Laboratories, Inc.1983-08-16360
K823214DOSIMETRIC RELEASE PROGRAM - ADMIN. SETCutter Laboratories, Inc.1983-01-12760
K821326CUTTER BOND POLYCARBOXYLATE CEMENTCutter Laboratories, Inc.1982-05-28240
K813532CUTTERBOND ZINC PHOSPHATE CEMENTCutter Laboratories, Inc.1982-03-02750
K802104C-SPLINTCutter Laboratories, Inc.1980-09-16130
K802105C-BLADECutter Laboratories, Inc.1980-09-16130
K801652TOTAL PARENTERAL NUTRITION SET BAGCutter Laboratories, Inc.1980-08-27400
K801651CUTTER JETCutter Laboratories, Inc.1980-08-13260
K800213PHARMACY ADDITIVE SYRINGE SETCutter Laboratories, Inc.1980-02-26250
K792250CUTTER POINTSCutter Laboratories, Inc.1980-01-23760
K792207PERIDIAL PERITONEAL DIALYSIS TRAYCutter Laboratories, Inc.1979-12-10380
K790125ULNAR HEAD PROTHESISCutter Laboratories, Inc.1979-02-08160
K781937PROTHESIS, METACARPALCutter Laboratories, Inc.1979-01-17580
K781521CUTTER RESIFLEX URINE METERCutter Laboratories, Inc.1978-11-22780
K781668GAMMA RADIATION STERILIZATION PRECEDURECutter Laboratories, Inc.1978-11-03360
K781059CUTTER/COMPUR MINI CENTRIFUGECutter Laboratories, Inc.1978-08-14490
K780624CULDOCENTESIS TRAYCutter Laboratories, Inc.1978-05-26420
K772225PATELLAR PROSTHESISCutter Laboratories, Inc.1977-12-0820
K770776TRAY, PRESSURE, INTRACOMPARTMENTAL,WICKCutter Laboratories, Inc.1977-08-04980
K770751CATHETERS, OVER-THE-NEEDLECutter Laboratories, Inc.1977-05-26310
K770678ELC-THERMO-SYSTEMCutter Laboratories, Inc.1977-05-25440
K770742CUTTER CAST 7Cutter Laboratories, Inc.1977-04-2860
K770619EXERCISOR, RESPIRATORYCutter Laboratories, Inc.1977-04-0760
K770469CUTTER TUNGSTEN CARBIDE BURSCutter Laboratories, Inc.1977-03-1660
K770392MUFFLER, AIR PUMPCutter Laboratories, Inc.1977-03-0770
K770376FILTER, NEBULIZER, CUTTERCutter Laboratories, Inc.1977-03-0140
K770375FILTER, AIR, CUTTER MAINLINECutter Laboratories, Inc.1977-03-0140
K760753CUTTER JEL-ALGINATE IMPRESSION MAT.Cutter Laboratories, Inc.1976-10-20190
K760755CUTTER SIL-SILICONE IMPRESSION MATCutter Laboratories, Inc.1976-10-15140
K760752CUTTER FLEX-SILICONE IMPRESSION MAT.Cutter Laboratories, Inc.1976-10-15140
K760754CUTTER TRAY-ACRYLIC FOR IMP TRAYSCutter Laboratories, Inc.1976-10-15140
K760744TAVERNETTI-TENNANTCutter Laboratories, Inc.1976-10-0770
K760422SURGICAL RETRACTORCutter Laboratories, Inc.1976-08-23130
K760235SUTURE GUIDECutter Laboratories, Inc.1976-07-26110
K760236BUR, SURGICAL CARBIDECutter Laboratories, Inc.1976-07-26110

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