510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Terragene LLC

Alvear Santa Fe, AR

TERRAGENE LLC appears in FDA device records in Alvear Santa Fe, AR. FDA records list 9 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
3
Registered establishments
2

510(k) clearance history

FDA records hold 9 510(k) clearances for Terragene LLC between 2017 and 2025. The busiest year on record is 2024, with 4. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Terragene LLC, by decision year
YearClearances
20171
20191
20201
20231
20244
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251122Terragene® Bionova® BT20 Biological IndicatorFRCSubstantially Equivalent
K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)FRCSubstantially Equivalent
K231383Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)FRCSubstantially Equivalent
DEN220042Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)QVBUnknown
K232103Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)QKMSubstantially Equivalent
K221641Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)FRCSubstantially Equivalent
K200272Terragene ChemdyeJOJSubstantially Equivalent
K191021Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene ChemdyeFRCSubstantially Equivalent
K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorFRCSubstantially Equivalent

Registered establishments

FDA registered establishments for Terragene LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30155373063015537306TERRAGENE LLC25003 Pitkin Rd Ste G400, Spring, TX 77386 US2026No device listings on this registration
30131453403013145340TERRAGENE SARuta Nacional No. 9, Km 280, Alvear Santa Fe 2130 AR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1248-2025ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.Class IIOpen, Classified
Z-0837-2024Terragene Bionova PCD (PCD222-C)Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.Class IIOpen, Classified
Z-0836-2024Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain